Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01379651
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2011-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021181', 'term': 'Egg Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'iridedello@hotmail.com', 'phone': '+39 824 771111', 'title': 'Dr. Iride Dello Iacono', 'organization': 'Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 month', 'eventGroups': [{'id': 'EG000', 'title': 'Specific Oral Tolerance Induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'controls were kept on an egg-free diet for 6 months', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 53, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'allergic reaction'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Specific Oral Tolerance Induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen'}, {'id': 'OG001', 'title': 'Control', 'description': 'controls were kept on an egg-free diet for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 6 months', 'description': 'To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Specific Oral Tolerance Induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen'}, {'id': 'OG001', 'title': 'Control', 'description': 'controls were kept on an egg-free diet for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '13'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.', 'unitOfMeasure': 'mm diameter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Specific Oral Tolerance Induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen'}, {'id': 'FG001', 'title': 'Control', 'description': 'controls were kept on an egg-free diet for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '26 children (14 boys, 12 girls; median age: 7 years 7 months; range 5-11 years), with severe IgE-mediated egg allergy (EA) were recruited from the Pediatric and Allergology Unit of the Fatebenefratelli Hospital in Benevento, Italy, from January 2008 to December 2009.', 'preAssignmentDetails': '6 children(4 males and 2 females)were excluded from the study: one child because the parents had a history of unreliable management of complications and treatments;2 children because of poorly controlled asthma;3 children because of a positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of raw egg emulsion higher than 0.9 ml.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Specific Oral Tolerance Induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen'}, {'id': 'BG001', 'title': 'Control', 'description': 'controls were kept on an egg-free diet for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.033', 'spread': '1.768', 'groupId': 'BG000'}, {'value': '7.676', 'spread': '3.203', 'groupId': 'BG001'}, {'value': '7.354', 'spread': '2.607', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-19', 'studyFirstSubmitDate': '2011-06-20', 'resultsFirstSubmitDate': '2011-06-24', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-01', 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg', 'timeFrame': 'baseline and 6 months', 'description': 'To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.'}], 'secondaryOutcomes': [{'measure': 'Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP', 'timeFrame': 'Baseline and 6 months', 'description': 'Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Egg allergy,specific oral tolerance induction'], 'conditions': ['- Egg Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '20355360', 'type': 'BACKGROUND', 'citation': 'Calvani M, Giorgio V, Miceli Sopo S. Specific oral tolerance induction for food. A systematic review. Eur Ann Allergy Clin Immunol. 2010 Feb;42(1):11-9.'}, {'pmid': '12777599', 'type': 'BACKGROUND', 'citation': 'Sampson HA. Anaphylaxis and emergency treatment. Pediatrics. 2003 Jun;111(6 Pt 3):1601-8.'}, {'pmid': '16455349', 'type': 'BACKGROUND', 'citation': 'Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. doi: 10.1016/j.jaci.2005.05.048.'}, {'pmid': '19076011', 'type': 'BACKGROUND', 'citation': 'Barbi E, Berti I, Longo G. Food allergy: from the of loss of tolerance induced by exclusion diets to specific oral tolerance induction. Recent Pat Inflamm Allergy Drug Discov. 2008 Nov;2(3):212-4. doi: 10.2174/187221308786241875.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.', 'detailedDescription': "Oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg. The children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit juice or other). The dose was doubled at intervals of about one month in the day hospital. The increases in dose were customized for each subject based on the frequency and severity of side effects, or when an inter-current illness or asthma worsening intervened during the SOTI.\n\nThe investigators limited the SOTI protocol to six months for all patients, irrespective of the dose reached, in order to favor the adherence of families to the study.\n\nWhen objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment was given. Subjects were discontinued from the study in case of severe adverse reactions (grade 5 reaction). Parents were advised they could telephone investigators 24 hours a day"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* at least 1 anaphylactic reaction (grade 3, 4 and 5 according to Sampson's grading after accidental exposure to trace amounts of egg or egg-derivative products, requiring emergency treatment, at least 1 year before enrollment\n* demonstration of egg white specific IgE by the skin prick test (SPT), end-point SPT, raw egg white prick-by-prick (PP) and egg white-specific IgE determination\n* positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of less than 0.9 ml of raw emulsion egg\n\nExclusion Criteria:\n\n* age below 5 years\n* poorly controlled asthma\n* parents with a history of unreliable management of complications and treatment."}, 'identificationModule': {'nctId': 'NCT01379651', 'acronym': 'EGGSOTI', 'briefTitle': 'Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Buon Consiglio Fatebenefratelli'}, 'officialTitle': 'Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol', 'orgStudyIdInfo': {'id': 'FBFBN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Specific oral tolerance induction', 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen', 'interventionNames': ['Other: Specific oral tolerance induction']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'controls were kept on an egg-free diet for 6 months'}], 'interventions': [{'name': 'Specific oral tolerance induction', 'type': 'OTHER', 'otherNames': ['SOTI'], 'description': 'Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg', 'armGroupLabels': ['Specific oral tolerance induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82100', 'city': 'Benevento', 'state': 'Benevento', 'country': 'Italy', 'facility': 'Unit of Pediatrics, Fatebenefratelli Hospital', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}], 'overallOfficials': [{'name': 'Iride Dello Iacono, pediatrician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Buon Consiglio Fatebenefratelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pediatrician', 'investigatorFullName': 'Iride Dello Iacono', 'investigatorAffiliation': 'Ospedale Buon Consiglio Fatebenefratelli'}}}}