Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 3:01 AM
Study NCT ID:
NCT02350660
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2015-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spc7w@virginia.edu', 'phone': '434.924.0000', 'title': 'Department of Medicine and Pediatrics', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Unblinded and without placebo control'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': "Cow's Milk for Alpha-gal Allergics", 'description': "daily consumption of cow's milk\n\ncow's milk: daily consumption of cow's milk", 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peanut Powder', 'description': 'peanut oral immunotherapy\n\npeanut powder: peanut oral immunotherapy', 'otherNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'food intolerance', 'notes': 'difficulty tolerating daily dosing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Level of Allergen Consumed Post-oral Immunotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Cow's Milk for Alpha-gal Allergics", 'description': "daily consumption of cow's milk\n\ncow's milk: daily consumption of cow's milk"}, {'id': 'OG001', 'title': 'Peanut Powder', 'description': 'peanut oral immunotherapy\n\npeanut powder: peanut oral immunotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '300', 'spread': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37', 'description': "consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.", 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Cow's Milk for Alpha-gal Allergics", 'description': "daily consumption of cow's milk\n\ncow's milk: daily consumption of cow's milk"}, {'id': 'FG001', 'title': 'Peanut Powder', 'description': 'peanut oral immunotherapy\n\npeanut powder: peanut oral immunotherapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Due to changes in funding structure, the study was unable to be completed with the designed number of participants and was therefore closed to enrollment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Cow's Milk for Alpha-gal Allergics", 'description': "daily consumption of cow's milk\n\ncow's milk: daily consumption of cow's milk"}, {'id': 'BG001', 'title': 'Peanut Powder', 'description': 'peanut oral immunotherapy\n\npeanut powder: peanut oral immunotherapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '7', 'groupId': 'BG000'}, {'value': '8', 'spread': '3', 'groupId': 'BG001'}, {'value': '23', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2015-01-21', 'resultsFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-02', 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Level of Allergen Consumed Post-oral Immunotherapy', 'timeFrame': 'Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37', 'description': "consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Food Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '25823600', 'type': 'DERIVED', 'citation': 'Wisniewski JA, Commins SP, Agrawal R, Hulse KE, Yu MD, Cronin J, Heymann PW, Pomes A, Platts-Mills TA, Workman L, Woodfolk JA. Analysis of cytokine production by peanut-reactive T cells identifies residual Th2 effectors in highly allergic children who received peanut oral immunotherapy. Clin Exp Allergy. 2015 Jul;45(7):1201-13. doi: 10.1111/cea.12537.'}]}, 'descriptionModule': {'briefSummary': 'Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.', 'detailedDescription': "In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence or absence of specific IgE to alpha-gal or peanut\n\nExclusion Criteria:\n\n* History of severe anaphylaxis\n* allergy to cow's milk protein"}, 'identificationModule': {'nctId': 'NCT02350660', 'briefTitle': 'Oral Immunotherapy for Peanut and Mammalian Meat Allergies', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Oral Immunotherapy for Peanut and Mammalian Meat Allergies', 'orgStudyIdInfo': {'id': '15098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Cow's milk for alpha-gal allergics", 'description': "daily consumption of cow's milk", 'interventionNames': ["Dietary Supplement: cow's milk"]}, {'type': 'EXPERIMENTAL', 'label': 'Peanut powder', 'description': 'peanut oral immunotherapy', 'interventionNames': ['Dietary Supplement: peanut powder']}], 'interventions': [{'name': "cow's milk", 'type': 'DIETARY_SUPPLEMENT', 'description': "daily consumption of cow's milk", 'armGroupLabels': ["Cow's milk for alpha-gal allergics"]}, {'name': 'peanut powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'peanut oral immunotherapy', 'armGroupLabels': ['Peanut powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Scott Commins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Medicine, Allergy and Immunology', 'investigatorFullName': 'Scott Commins, MD', 'investigatorAffiliation': 'University of Virginia'}}}}