Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT01259804
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2010-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tolerance to Oral Peanut
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pass/fail peanut challenge', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peanut', 'food allergy', 'anaphylaxis', 'immunotherapy'], 'conditions': ['Peanut Allergy']}, 'referencesModule': {'references': [{'pmid': '19226304', 'type': 'RESULT', 'citation': 'Clark AT, Islam S, King Y, Deighton J, Anagnostou K, Ewan PW. Successful oral tolerance induction in severe peanut allergy. Allergy. 2009 Aug;64(8):1218-20. doi: 10.1111/j.1398-9995.2009.01982.x. Epub 2009 Feb 17.'}, {'pmid': '31676085', 'type': 'DERIVED', 'citation': 'Santos AF, James LK, Kwok M, McKendry RT, Anagnostou K, Clark AT, Lack G. Peanut oral immunotherapy induces blocking antibodies but does not change the functional characteristics of peanut-specific IgE. J Allergy Clin Immunol. 2020 Jan;145(1):440-443.e5. doi: 10.1016/j.jaci.2019.09.005. Epub 2019 Oct 30. No abstract available.'}, {'pmid': '21414048', 'type': 'DERIVED', 'citation': 'Anagnostou K, Clark A, King Y, Islam S, Deighton J, Ewan P. Efficacy and safety of high-dose peanut oral immunotherapy with factors predicting outcome. Clin Exp Allergy. 2011 Sep;41(9):1273-81. doi: 10.1111/j.1365-2222.2011.03699.x. Epub 2011 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy', 'detailedDescription': 'Background Peanut allergy is severe and rarely resolves.\n\nObjective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.\n\nMethod 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peanut allergy defined by oral challenge\n\nExclusion Criteria:\n\n* Major immunodeficiency'}, 'identificationModule': {'nctId': 'NCT01259804', 'acronym': 'STOP', 'briefTitle': 'Study of Tolerance to Oral Peanut', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome', 'orgStudyIdInfo': {'id': 'STOP-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peanut immunotherapy', 'description': 'Peanut flour', 'interventionNames': ['Dietary Supplement: Peanut oral immunotherapy']}], 'interventions': [{'name': 'Peanut oral immunotherapy', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Daily doses peanut flour'], 'description': 'Daily doses of peanut flour', 'armGroupLabels': ['Peanut immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB23 7DS', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge Biomedical Campus', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Andrew T Clark, MB BD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge Biomedical Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Dr. Andrew Clark', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}