Viewing Study NCT02017405

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Ignite Creation Date: 2025-12-25 @ 3:13 AM
Ignite Modification Date: 2026-02-25 @ 6:34 PM
Study NCT ID: NCT02017405
Status: COMPLETED
Last Update Posted: 2024-09-19
First Post: 2013-12-10
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'audrey.shaw@enterahealth.com', 'phone': '919 971 8000', 'title': 'Audrey L. Shaw, Ph.D.', 'organization': 'Entera Health, Inc.'}, 'certainAgreement': {'otherDetails': '45 days', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 Days', 'eventGroups': [{'id': 'EG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase', 'description': 'Subjects that received 5g SBI on either day 1 or day 2 of the crossover phase and reported AE during crossover phase.\n\nThis includes groups 1A and 1B in the crossover phase.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase', 'description': 'Subjects that received 10g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase.\n\nThis includes groups 2A and 2B in the crossover phase.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase', 'description': 'Subjects that received 20g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase.\n\nThis includes groups 3A and 3B in the crossover phase.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo - Crossover Phase', 'description': 'Subjects that received 5, 10, or 20g placebo dose on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes all subjects in the crossover phase.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase', 'description': 'Patients that took 2.5g SBI BID (5g daily) during 14 day open label phase. Reported AE during 14 day open label phase.\n\nThis includes groups 1A and 1B in the open label phase.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase', 'description': 'Patients that took 5g SBI BID (10g daily) during 14 day open label phase. Reported AE during 14 day open label phase.\n\nThis includes groups 2A and 2B in the open label phase.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase', 'description': 'Patients that took 10g SBI BID (20g daily) during 14 day open label phase. Reported AE during 14 day open label phase.\n\nThis includes groups 3A and 3B in the open label phase.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'notes': 'The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in left leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Running nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bloated Feeling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Common Cold', 'notes': 'The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'notes': 'One subject in the 20g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'notes': 'The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Knee Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gum Shifting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Total Plasma Amino Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 5.0g total daily dose of SBI on Day 1 or 5.0g SBI on Day 2 during the double-blind, crossover phase.\n\nThis includes group 1A and 1B.'}, {'id': 'OG001', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 10.0g total daily dose of SBI on Day 1 or 10.0g SBI on Day 2 during the double-blind, crossover phase.\n\nThis includes group 2A and 2B.'}, {'id': 'OG002', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 20.0g total daily dose of SBI on Day 1 or 20.0g SBI on Day 2 during the double-blind, crossover phase.\n\nThis includes group 3A and 3B.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects who will receive a placebo dose(5,10, or 20g) on either day one or two of the crossover phase.\n\nThis includes all subjects who finished the crossover phase, as all subjects received a placebo.'}], 'classes': [{'title': 'Mean - 0 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2730.87', 'spread': '695.33', 'groupId': 'OG000'}, {'value': '2988.94', 'spread': '758.92', 'groupId': 'OG001'}, {'value': '2964.19', 'spread': '583.50', 'groupId': 'OG002'}, {'value': '2869.14', 'spread': '647.01', 'groupId': 'OG003'}]}]}, {'title': 'Mean - 180 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2723.72', 'spread': '557.53', 'groupId': 'OG000'}, {'value': '2785.20', 'spread': '483.77', 'groupId': 'OG001'}, {'value': '2893.69', 'spread': '705.36', 'groupId': 'OG002'}, {'value': '2736.58', 'spread': '583.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 180 minutes following administration of the investigational product in crossover phase.', 'description': 'Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.', 'unitOfMeasure': 'umol/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During 2-day cross-over phase, subjects were randomized to receive placebo one day and active on the other. This includes all subjects who received both a placebo and an active dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Quantifiable Bovine IgG Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 5.0g total daily dose of SBI on Day 1 or 5.0g SBI on Day 2 during the double-blind crossover phase. Then took 2.5g BID (5.0g daily) during the 14 day open label phase.\n\nThis includes group 1A and 1B.'}, {'id': 'OG001', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 10.0g total daily dose of SBI on Day 1 or 10.0g SBI on Day 2 during the double-blind crossover phase. Then took 5.0g BID (10.0g daily) during the 14 day open label phase.\n\nThis includes group 2A and 2B.'}, {'id': 'OG002', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who will receive either a 20.0g total daily dose of SBI on Day 1 or 20.0g SBI on Day 2 during the double-blind crossover phase. Then took 10.0g BID (20.0g daily) during the 14 day open label phase.\n\nThis includes group 3A and 3B.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Subjects who will receive a placebo dose(5,10, or 20g) on either day one or two of the crossover phase. No open label phase as there is no placebo.'}], 'classes': [{'title': '0 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '90 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Post 14 days of open label dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing', 'description': 'Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of SBI. Variations in numbers from the participation flow are due to missing data of certain individuals.'}, {'type': 'SECONDARY', 'title': 'Bovine IgG Concentration in Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who take 2.5g SBI BID (5.0g daily) for 14 days during the open-label phase.'}, {'id': 'OG001', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who take 5.0g SBI BID (10.0g daily) for 14 days during the open-label phase.'}, {'id': 'OG002', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Subjects who take 10.0g SBI BID (20.0g daily) for 14 days during the open-label phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.79', 'spread': '80.01', 'groupId': 'OG000'}, {'value': '160.20', 'spread': '121.09', 'groupId': 'OG001'}, {'value': '111.59', 'spread': '76.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days after starting the open label phase', 'description': 'Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.', 'unitOfMeasure': 'pg/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of product and had at least one stool IgG measurement. No placebo as there is no placebo group in the open label phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1A', 'description': 'Crossover Phase:\n\n5.0g total daily dose of SBI on Day 1 followed by 5.0g Placebo on Day 2\n\nOpen Label Phase:\n\n5.0g total daily dose of SBI will be taken for 14 days'}, {'id': 'FG001', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1B', 'description': 'Crossover Phase:\n\n5.0g total daily dose of Placebo on Day 1 followed by 5.0g SBI on Day 2\n\nOpen Label Phase:\n\n5.0g total daily dose of SBI will be taken for 14 days'}, {'id': 'FG002', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2A', 'description': 'Crossover Phase:\n\n10.0g total daily dose of SBI on Day 1 followed by 10.0g Placebo on Day 2\n\nOpen Label Phase:\n\n10.0g total daily dose of SBI will be taken for 14 days'}, {'id': 'FG003', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2B', 'description': 'Crossover Phase:\n\n10.0g total daily dose of Placebo on Day 1 followed by 10.0g SBI on Day 2.\n\nOpen Label Phase:\n\n10.0g total daily dose of SBI will be taken for 14 days'}, {'id': 'FG004', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3A', 'description': 'Crossover Phase:\n\n20.0g total daily dose of SBI on Day 1 followed by 20.0g placebo on day 2.\n\nOpen Label Phase:\n\n20.0g total daily dose of SBI will be taken for 14 days'}, {'id': 'FG005', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3B', 'description': 'Crossover Phase:\n\n20.0g total daily dose of Placebo on Day 1 followed by 20.0g SBI on Day 2\n\nOpen Label Phase:\n\n20.0g total daily dose of SBI will be taken for 14 days'}], 'periods': [{'title': 'Two-day, Double-blind, Crossover Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Dosing errors occurred in six subjects during the double-blind, crossover phase. Four subjects assigned to 10g of SBI received 5g of SBI and two subjects assigned to 20g of SBI received 10g of SBI. An additional six subjects were added to the 2-day, double-blind, crossover phase to ensure \\~12 subjects per SBI gram dosage group.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'comment': 'Patient withdrew after receiving placebo dose and prior to receiving 20g SBI dose.', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Dosing errors occurred in six subjects during the double-blind, crossover phase. These six subjects continued with the originally assigned dose of SBI for the 14-day, open-label phase of the study. This led to a difference in number of participants who completed phase 1 and started phase 2.', 'achievements': [{'comment': 'No placebo in the open label phase', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'No placebo in the open label phase', 'groupId': 'FG001', 'numSubjects': '7'}, {'comment': 'No placebo in the open label phase', 'groupId': 'FG002', 'numSubjects': '7'}, {'comment': 'No placebo in the open label phase', 'groupId': 'FG003', 'numSubjects': '7'}, {'comment': 'No placebo in the open label phase', 'groupId': 'FG004', 'numSubjects': '7'}, {'comment': 'No placebo in the open label phase', 'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 5.0 g total daily dose of SBI on Day 1 followed by 5.0 g Placebo on Day 2 or a 5.0 g total daily dose of Placebo on Day 1 followed by 5.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 2.5g SBI will be taken two times a day for 14 days during the open-label phase.'}, {'id': 'BG001', 'title': '10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 10.0 g total daily dose of SBI on Day 1 followed by 10.0 g Placebo on Day 2 or a 10.0 g total daily dose of Placebo on Day 1 followed by 10.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 5.0 g SBI will taken two times a day for 14 days during the open-label phase.'}, {'id': 'BG002', 'title': '20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 20.0 g total daily dose of SBI on Day 1 followed by 20.0 g Placebo on Day 2 or a 20.0 g total daily dose of Placebo on Day 1 followed by 20.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 20.0 g SBI will be taken two times a day for 14 days during the open-label phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '9.66', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '16.64', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '13.26', 'groupId': 'BG002'}, {'value': '40.2', 'spread': '13.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2013-12-10', 'resultsFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-05', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Total Plasma Amino Acids', 'timeFrame': '0, 180 minutes following administration of the investigational product in crossover phase.', 'description': 'Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Quantifiable Bovine IgG Plasma Concentration', 'timeFrame': '0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing', 'description': 'Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605).'}, {'measure': 'Bovine IgG Concentration in Stool', 'timeFrame': '14 days after starting the open label phase', 'description': 'Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Digestibility', 'Healthy volunteers', 'serum-derived bovine immunoglobulin protein isolate', 'bovine IgG', 'adults'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.enteragam.com/', 'label': 'EnteraGam™'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.", 'detailedDescription': 'This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index of 18-32\n* Medically normal with no significant abnormal findings at screening\n\nExclusion Criteria:\n\n* Allergy or intolerance to beef\n* Participated in another investigational study within 30 days\n* Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus'}, 'identificationModule': {'nctId': 'NCT02017405', 'briefTitle': 'Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entera Health, Inc'}, 'officialTitle': 'A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults', 'orgStudyIdInfo': {'id': 'EH4001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '5g Serum-derived bovine immunoglobulin protein isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 5.0 g total daily dose of SBI on Day 1 followed by 5.0 g Placebo on Day 2 or a 5.0 g total daily dose of Placebo on Day 1 followed by 5.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 2.5g SBI will be taken two times a day for 14 days during the open-label phase.', 'interventionNames': ['Other: Serum-derived bovine immunoglobulin protein isolate (SBI)']}, {'type': 'OTHER', 'label': '10g Serum-derived bovine immunoglobulin protein isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 10.0 g total daily dose of SBI on Day 1 followed by 10.0 g Placebo on Day 2 or a 10.0 g total daily dose of Placebo on Day 1 followed by 10.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 5.0 g SBI will taken two times a day for 14 days during the open-label phase.', 'interventionNames': ['Other: Serum-derived bovine immunoglobulin protein isolate (SBI)']}, {'type': 'OTHER', 'label': '20g Serum-derived bovine immunoglobulin protein isolate (SBI)', 'description': 'Phase 1: Twelve subjects will receive either a 20.0 g total daily dose of SBI on Day 1 followed by 20.0 g Placebo on Day 2 or a 20.0 g total daily dose of Placebo on Day 1 followed by 20.0 g SBI on Day 2 during the double-blind, crossover phase.\n\nPhase 2: 20.0 g SBI will be taken two times a day for 14 days during the open-label phase.', 'interventionNames': ['Other: Serum-derived bovine immunoglobulin protein isolate (SBI)']}, {'type': 'OTHER', 'label': 'Matching Placebo', 'description': 'Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.', 'interventionNames': ['Other: Matching Placebo']}], 'interventions': [{'name': 'Serum-derived bovine immunoglobulin protein isolate (SBI)', 'type': 'OTHER', 'otherNames': ['EnteraGam™'], 'description': 'Serum-derived bovine immunoglobulin protein isolate is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. Serum-derived bovine immunoglobulin protein isolate does not contain any milk products such as lactose, casein, or whey. Serum-derived bovine immunoglobulin protein isolate is gluten-free, dye-free, and soy-free. Serum-derived bovine immunoglobulin protein isolate is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.', 'armGroupLabels': ['10g Serum-derived bovine immunoglobulin protein isolate (SBI)', '20g Serum-derived bovine immunoglobulin protein isolate (SBI)', '5g Serum-derived bovine immunoglobulin protein isolate (SBI)']}, {'name': 'Matching Placebo', 'type': 'OTHER', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Cary', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Eric Weaver, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Entera Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entera Health, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}