Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-26 @ 4:46 PM
Study NCT ID:
NCT00778258
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Milk Allergy and Tolerance in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '301-594-7669', 'title': 'Director, Clinical Research Operations Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Enrollment through end of study (up to 3 years)', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dose Escalation - Reacted to Rice Pudding', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose Escalation - Reacted to Non-baked Milk', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Maintenance - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Maintenance - Reacted to Rice Pudding', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Maintenance - Reacted to Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.', 'otherNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Not Randomized - Comparison', 'description': 'Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups', 'otherNumAtRisk': 34, 'otherNumAffected': 20, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Non-Randomized - Reacted to Muffin', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months', 'otherNumAtRisk': 41, 'otherNumAffected': 40, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Non-Randomized - Tolerant to Baked and Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Growth hormone deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eosinophilic oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Allergy to animal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 53, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 31, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 66, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 48, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 104, 'numAffected': 39}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 40, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 24, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 49, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 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'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-Escalation Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.'}, {'id': 'OG001', 'title': 'Maintenance Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.93', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': 'Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-Escalation Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.\\[Dose Escalation arm\\].'}, {'id': 'OG001', 'title': 'Maintenance Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.\\[Maintenance arm\\].'}], 'classes': [{'title': 'Progressed at 12 Months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Progressed at 24 Months', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.68', 'groupDescription': 'Progression comparison at 12 Months', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.91', 'groupDescription': 'Progression comparison at 24 Months', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months, 24 months', 'description': 'Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized intent-to-treat'}, {'type': 'SECONDARY', 'title': "Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-Escalation Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.\\[Dose Escalation arm\\].'}, {'id': 'OG001', 'title': 'Maintenance Group', 'description': 'Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.\\[Maintenance arm\\].'}], 'classes': [{'title': 'Tolerant at 12 Month', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}]}]}, {'title': 'Tolerant at 24 Months', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}, {'title': 'Tolerant at 36 Months', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}, {'value': '43.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison at 12 Months', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison at 24 Months', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison at 36 Months', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months, 24 months, and 36 months', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized intent-to-treat'}, {'type': 'SECONDARY', 'title': "Percent of Participants Becoming Tolerant to Unheated Cow's Milk", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 - Pizza', 'description': 'Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge'}, {'id': 'OG001', 'title': 'Group 3 - Rice Pudding', 'description': 'Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge'}, {'id': 'OG002', 'title': 'Group 4 - Milk', 'description': 'Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '53.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 = Muffin', 'description': 'Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge'}, {'id': 'OG001', 'title': 'Group 2 = Pizza', 'description': 'Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge'}, {'id': 'OG002', 'title': 'Group 3 = Rice Pudding', 'description': 'Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge'}, {'id': 'OG003', 'title': 'Group 4 = Milk', 'description': 'Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge'}, {'id': 'OG004', 'title': 'Group 5 = Passed All', 'description': 'Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '76.7'}, {'value': '29.3', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '47.8'}, {'value': '45.6', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '85.3'}, {'value': '20.3', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '55.1'}, {'value': '8.9', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '32.1'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'statisticalMethod': "Spearman's Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.', 'unitOfMeasure': 'percentage of max basophil degranulation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 = Muffin', 'description': 'Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge'}, {'id': 'OG001', 'title': 'Group 2 = Pizza', 'description': 'Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge'}, {'id': 'OG002', 'title': 'Group 3 = Rice Pudding', 'description': 'Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge'}, {'id': 'OG003', 'title': 'Group 4 = Milk', 'description': 'Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge'}, {'id': 'OG004', 'title': 'Group 5 = Passed All', 'description': 'Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit'}], 'classes': [{'title': 'Beta-lactoglobulin IgE', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.4'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '3.5'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '2.3'}, {'value': '0.2', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Casein IgE', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '17.9'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '9.6'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '12.9'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '3.6'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}, {'title': "Cow's Milk IgE", 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '21.1'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '12.2'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '19.1'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.6'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '4.3'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'groupDescription': 'Analysis on Betalactoglobulin', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'groupDescription': 'Analysis on Betalactoglobulin IgE', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Analysis on Casein IgE', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'groupDescription': 'Analysis on Casein IgE', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': "Analysis on Cow's Milk IgE", 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'groupDescription': "Analysis on Cow's Milk IgE", 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.', 'unitOfMeasure': 'kUa/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 = Muffin', 'description': 'Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge'}, {'id': 'OG001', 'title': 'Group 2 = Pizza', 'description': 'Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge'}, {'id': 'OG002', 'title': 'Group 3 = Rice Pudding', 'description': 'Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge'}, {'id': 'OG003', 'title': 'Group 4 = Milk', 'description': 'Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge'}, {'id': 'OG004', 'title': 'Group 5 = Passed All', 'description': 'Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit'}], 'classes': [{'title': 'Max Basophil Assessment', 'categories': [{'measurements': [{'value': '1160.0', 'groupId': 'OG000', 'lowerLimit': '635.0', 'upperLimit': '1981.0'}, {'value': '717.0', 'groupId': 'OG001', 'lowerLimit': '456.0', 'upperLimit': '982.0'}, {'value': '1589.5', 'groupId': 'OG002', 'lowerLimit': '1287.5', 'upperLimit': '3972.0'}, {'value': '934.0', 'groupId': 'OG003', 'lowerLimit': '459.0', 'upperLimit': '1669.0'}, {'value': '524.0', 'groupId': 'OG004', 'lowerLimit': '319.0', 'upperLimit': '1087.0'}]}]}, {'title': 'Tregs', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '7.0'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '8.5'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '12.5'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '10.1'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '2.2', 'upperLimit': '8.5'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'groupDescription': 'Analysis on Max Basophil Assessment', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'groupDescription': 'Analysis on Max Basophil Assessment', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'groupDescription': 'Analysis on Tregs', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.32', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Null hypothesis is that correlation = 0', 'groupDescription': 'Analysis on Tregs', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 - Pizza', 'description': 'Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge'}, {'id': 'OG001', 'title': 'Group 3 - Rice Pudding', 'description': 'Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge'}, {'id': 'OG002', 'title': 'Group 4 - Milk', 'description': 'Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '19.6', 'spread': '10.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.", 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized intent-to-treat participants who achieved tolerance'}, {'type': 'SECONDARY', 'title': 'Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 = Muffin', 'description': 'Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge'}, {'id': 'OG001', 'title': 'Group 2 = Pizza', 'description': 'Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge'}, {'id': 'OG002', 'title': 'Group 3 = Rice Pudding', 'description': 'Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge'}, {'id': 'OG003', 'title': 'Group 4 = Milk', 'description': 'Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge'}, {'id': 'OG004', 'title': 'Group 5 = Passed All', 'description': 'Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.5'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '9.0'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '14.2'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.6'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.4'}]}]}, {'title': 'Month 12 Visit', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '20.7'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '12.2'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '11.5'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '4.3'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Month 24 Visit', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '7.6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '9.2'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '171.2'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '6.2'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '3.7'}]}]}, {'title': 'Month 36 Visit', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '9.0'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '13.7'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '6.2'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '2.6'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '27.3'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Correlation = -0.18', 'groupDescription': 'Baseline Comparison', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Correlation = -0.34', 'groupDescription': 'Month 12 Comparison', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.156', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Correlation = -0.20', 'groupDescription': 'Month 24 Comparison', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.077', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Correlation = -0.27', 'groupDescription': 'Month 36 Comparison', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 12, Month 24, Month 36', 'description': 'Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'This group included participants who were in baseline groups 2 through 4.'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': 'This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study'}, {'id': 'OG002', 'title': 'Reacted to Muffin', 'description': 'This group included participants who were in baseline group 1'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': '36 Month Comparison', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 36', 'description': "Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.", 'unitOfMeasure': 'percent participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized and comparison participants'}, {'type': 'SECONDARY', 'title': 'Changes in Mechanistic Values [Humoral, T Cell and Basophil]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'This group included participants who were in baseline groups 2 through 4.'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': 'This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study'}, {'id': 'OG002', 'title': 'Reacted to Muffin', 'description': 'This group included participants who were in baseline group 1'}], 'timeFrame': 'Baseline, Month 12, Month 24, and Month 36', 'description': 'This outcome measure was not well defined in the protocol and was not analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and therefore no analyses could be performed.'}, {'type': 'SECONDARY', 'title': 'Changes in Mechanistic Values [Humoral, T Cell and Basophil]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'This group included participants who were in baseline groups 2 through 4.'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': 'This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study'}, {'id': 'OG002', 'title': 'Reacted to Muffin', 'description': 'This group included participants who were in baseline group 1'}], 'timeFrame': 'Baseline to the time complete milk tolerance was established', 'description': 'This outcome measure was not well defined in the protocol and was not analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and therefore no analyses could be performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Escalation - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG001', 'title': 'Dose Escalation - Reacted to Rice Pudding', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG002', 'title': 'Dose Escalation - Reacted to Non-baked Milk', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG003', 'title': 'Maintenance - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG004', 'title': 'Maintenance - Reacted to Rice Pudding', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG005', 'title': 'Maintenance- Reacted to Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'FG006', 'title': 'Not Randomized - Comparison', 'description': 'Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups'}, {'id': 'FG007', 'title': 'Non-Randomized - Reacted to Muffin', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months'}, {'id': 'FG008', 'title': 'Non-Randomized - Tolerant to Baked and Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '34'}, {'groupId': 'FG007', 'numSubjects': '41'}, {'groupId': 'FG008', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'New Contraindication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '170', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Escalation - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG001', 'title': 'Dose Escalation - Reacted to Rice Pudding', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG002', 'title': 'Dose Escalation - Reacted to Non-baked Milk', 'description': 'At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG003', 'title': 'Maintenance - Reacted to Pizza', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG004', 'title': 'Maintenance - Reacted to Rice Pudding', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG005', 'title': 'Maintenance- Reacted to Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.'}, {'id': 'BG006', 'title': 'Not Randomized - Comparison', 'description': 'Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups'}, {'id': 'BG007', 'title': 'Non-Randomized - Reacted to Muffin', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months'}, {'id': 'BG008', 'title': 'Non-Randomized - Tolerant to Baked and Non-baked Milk', 'description': 'At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '7.3', 'spread': '2.2', 'groupId': 'BG003'}, {'value': '6.7', 'spread': '2.7', 'groupId': 'BG004'}, {'value': '6.3', 'spread': '2.1', 'groupId': 'BG005'}, {'value': '6.5', 'spread': '2.3', 'groupId': 'BG006'}, {'value': '7.5', 'spread': '1.9', 'groupId': 'BG007'}, {'value': '6.5', 'spread': '2.2', 'groupId': 'BG008'}, {'value': '6.9', 'spread': '2.2', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '52', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '118', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '38', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '159', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '141', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '170', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Boiled Milk Wheal', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '7.6', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '7.6', 'spread': '2.0', 'groupId': 'BG004'}, {'value': '5.5', 'spread': '3.2', 'groupId': 'BG005'}, {'value': '7.7', 'spread': '4.5', 'groupId': 'BG006'}, {'value': '7.9', 'spread': '2.6', 'groupId': 'BG007'}, {'value': '3.4', 'spread': '2.5', 'groupId': 'BG008'}, {'value': '6.9', 'spread': '3.2', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': 'A skin prick test (SPT) measured the presence of immunoglobulin E (IgE) antibodies for the food tested. During the SPT, a drop of solution containing the food allergen was placed on the forearm. Using a small plastic needle, the skin was gently pricked or scratched to allow a tiny amount of the solution to enter just below the surface. After 15 minutes, positive results were indicated by a wheal, a raised white bump surrounded by a small circle of red skin. The wheal was measured in millimeters. Larger sizes indicated a greater chance of experiencing an allergic reaction to the food tested.', 'unitOfMeasure': 'Mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Milk Extract Wheal', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '3.4', 'groupId': 'BG002'}, {'value': '8.9', 'spread': '2.8', 'groupId': 'BG003'}, {'value': '8.1', 'spread': '2.7', 'groupId': 'BG004'}, {'value': '8.5', 'spread': '3.4', 'groupId': 'BG005'}, {'value': '9.0', 'spread': '3.8', 'groupId': 'BG006'}, {'value': '10.5', 'spread': '3.7', 'groupId': 'BG007'}, {'value': '5.0', 'spread': '2.6', 'groupId': 'BG008'}, {'value': '8.9', 'spread': '3.4', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': 'A skin prick test (SPT) measured the presence of immunoglobulin E (IgE) antibodies for the food tested. During the SPT, a drop of solution containing the food allergen was placed on the forearm. Using a small plastic needle, the skin was gently pricked or scratched to allow a tiny amount of the solution to enter just below the surface. After 15 minutes, positive results were indicated by a wheal, a raised white bump surrounded by a small circle of red skin. The wheal was measured in millimeters. Larger sizes indicated a greater chance of experiencing an allergic reaction to the food tested.', 'unitOfMeasure': 'Mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Unheated Milk Wheal', 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '11.6', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '2.3', 'groupId': 'BG003'}, {'value': '10.0', 'spread': '2.7', 'groupId': 'BG004'}, {'value': '9.7', 'spread': '4.0', 'groupId': 'BG005'}, {'value': '9.6', 'spread': '4.3', 'groupId': 'BG006'}, {'value': '10.1', 'spread': '2.6', 'groupId': 'BG007'}, {'value': '5.6', 'spread': '2.8', 'groupId': 'BG008'}, {'value': '9.3', 'spread': '3.4', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': 'A skin prick test (SPT) measured the presence of immunoglobulin E (IgE) antibodies for the food tested. During the SPT, a drop of solution containing the food allergen was placed on the forearm. Using a small plastic needle, the skin was gently pricked or scratched to allow a tiny amount of the solution to enter just below the surface. After 15 minutes, positive results were indicated by a wheal, a raised white bump surrounded by a small circle of red skin. The wheal was measured in millimeters. Larger sizes indicated a greater chance of experiencing an allergic reaction to the food tested.', 'unitOfMeasure': 'Mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Baseline Cow's Milk IgE", 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '5.4', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '13.7', 'spread': '13.1', 'groupId': 'BG004'}, {'value': '4.1', 'spread': '4.5', 'groupId': 'BG005'}, {'value': '14.7', 'spread': '21.3', 'groupId': 'BG006'}, {'value': '15.1', 'spread': '12.7', 'groupId': 'BG007'}, {'value': '4.9', 'spread': '8.1', 'groupId': 'BG008'}, {'value': '10.6', 'spread': '13.6', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': "When cow's milk immunoglobulin E (IgE) antibodies are present in serum samples, this is indicative of a potential for an allergic reaction to cow's milk. The greater the concentration of IgE antibodies present, the more likely an allergic reaction to cow's milk is to occur.", 'unitOfMeasure': 'kUa/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All Enrolled'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2008-10-21', 'resultsFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-29', 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm', 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': 'Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months', 'timeFrame': '12 months, 24 months', 'description': 'Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.'}, {'measure': "Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months", 'timeFrame': '12 months, 24 months, and 36 months', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC."}, {'measure': "Percent of Participants Becoming Tolerant to Unheated Cow's Milk", 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC."}, {'measure': 'Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.'}, {'measure': 'Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.'}, {'measure': 'Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity', 'timeFrame': 'Baseline', 'description': 'This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.'}, {'measure': 'Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance', 'timeFrame': 'Randomization through end of study (up to 36 months)', 'description': "Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk."}, {'measure': 'Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey', 'timeFrame': 'Baseline, Month 12, Month 24, Month 36', 'description': 'Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.'}, {'measure': 'Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk', 'timeFrame': 'Month 36', 'description': "Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk."}, {'measure': 'Changes in Mechanistic Values [Humoral, T Cell and Basophil]', 'timeFrame': 'Baseline, Month 12, Month 24, and Month 36', 'description': 'This outcome measure was not well defined in the protocol and was not analyzed.'}, {'measure': 'Changes in Mechanistic Values [Humoral, T Cell and Basophil]', 'timeFrame': 'Baseline to the time complete milk tolerance was established', 'description': 'This outcome measure was not well defined in the protocol and was not analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Food Allergy', 'Milk Allergy'], 'conditions': ['Food Hypersensitivity', 'Milk Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '18620743', 'type': 'BACKGROUND', 'citation': "Nowak-Wegrzyn A, Bloom KA, Sicherer SH, Shreffler WG, Noone S, Wanich N, Sampson HA. Tolerance to extensively heated milk in children with cow's milk allergy. J Allergy Clin Immunol. 2008 Aug;122(2):342-7, 347.e1-2. doi: 10.1016/j.jaci.2008.05.043. Epub 2008 Jul 11."}, {'pmid': '17935766', 'type': 'BACKGROUND', 'citation': "Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1."}, {'pmid': '17919140', 'type': 'BACKGROUND', 'citation': 'Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy. 2007 Nov;62(11):1261-9. doi: 10.1111/j.1398-9995.2007.01501.x.'}, {'pmid': '17895338', 'type': 'BACKGROUND', 'citation': "Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, Staiano A, Dupont C. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. doi: 10.1136/adc.2006.110999."}], 'seeAlsoLinks': [{'url': 'http://www.niaid.nih.gov/TOPICS/ASTHMA/RESEARCH/Pages/AADCRCs.aspx', 'label': 'Description of NIAID Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) Program'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.', 'detailedDescription': 'Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, some have been known to tolerate milk products cooked at high heat such as when baked in foods.\n\nThis clinical trial involves a diet containing extensively baked milk protein to investigate the effects of ingestion of heat-denatured milk on development of oral tolerance to non-baked milk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOne or more of the following inclusion criteria for enrollment in the study have to be met:\n\n* Convincing history of an allergic reaction to milk or a positive double blind placebo controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk immunoglobulin E (IgE) or positive prick skin test to milk OR\n* Serum milk-IgE of high predictive value \\>14 kUa/L or prick skin test to milk \\> 10mm wheal within the past 6 months regardless of past clinical history of reactions OR\n* Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2 years ago and either a positive serum milk-IgE \\< 14 kUA/L or positive prick skin test to milk \\< 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges)\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or to comply with study protocol'}, 'identificationModule': {'nctId': 'NCT00778258', 'briefTitle': 'Study of Milk Allergy and Tolerance in Children', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Dietary Intervention in Milk Allergy and Tolerance Development', 'orgStudyIdInfo': {'id': 'DAIT AADCRC-MSSM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milk-allergic; Non-consumption', 'description': 'Subjects in this arm reacted to the lowest baseline dose of baked milk (muffin) and will continue strict milk avoidance, returning for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months. Individual participants may be challenged at 12 and or 24 months.', 'interventionNames': ['Biological: Baked Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Tolerated Muffin, Reacted to Pizza', 'description': 'Subjects will be assigned to this arm, if they can tolerate ingesting a muffin but react to ingesting the amount of baked milk in a standardized portion of pizza. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.', 'interventionNames': ['Biological: Baked Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Reacted to Rice Pudding', 'description': 'Subjects will be assigned to this arm, if they can tolerate ingesting a muffin and a standardized portion of pizza but react to a standardized dose of baked milk in rice pudding. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.', 'interventionNames': ['Biological: Baked Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Reacted to Non-baked Milk', 'description': 'Subjects will be assigned to this arm, if they can tolerate ingesting a muffin, pizza and rice pudding but react to a standardized dose of non-baked milk. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.', 'interventionNames': ['Biological: Baked Milk', 'Biological: Non-baked Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Tolerant to Baked and Non-baked Milk', 'description': 'Biological/Vaccine: Baked Milk At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.\n\nBiological/Vaccine: Non-baked Milk Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.', 'interventionNames': ['Biological: Baked Milk', 'Biological: Non-baked Milk']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Interventional Comparison', 'description': 'Thirty subjects who fulfill inclusion criteria but are unwilling to participate in the full protocol will be enrolled as a comparison group to the active arms.'}], 'interventions': [{'name': 'Baked Milk', 'type': 'BIOLOGICAL', 'description': 'At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.', 'armGroupLabels': ['Milk-allergic; Non-consumption', 'Reacted to Non-baked Milk', 'Reacted to Rice Pudding', 'Tolerant to Baked and Non-baked Milk', 'Tolerated Muffin, Reacted to Pizza']}, {'name': 'Non-baked Milk', 'type': 'BIOLOGICAL', 'description': 'Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.', 'armGroupLabels': ['Reacted to Non-baked Milk', 'Tolerant to Baked and Non-baked Milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Hugh A. Sampson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Anna Nowak-Wegrzyn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Asthma and Allergic Diseases Cooperative Research Centers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}