Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT01164293
Status:
COMPLETED
Last Update Posted:
2015-09-18
First Post:
2010-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2010-07-15', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms', 'timeFrame': '3 days', 'description': 'To evaluate (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test.'}], 'secondaryOutcomes': [{'measure': 'Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen', 'timeFrame': '3 days', 'description': 'To evaluate (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atopy patch test'], 'conditions': ['Food Allergy']}, 'referencesModule': {'references': [{'pmid': '27979025', 'type': 'DERIVED', 'citation': 'Visitsunthorn N, Chatpornvorarux S, Pacharn P, Jirapongsananuruk O. Atopy patch test in children with atopic dermatitis. Ann Allergy Asthma Immunol. 2016 Dec;117(6):668-673. doi: 10.1016/j.anai.2016.09.446.'}]}, 'descriptionModule': {'briefSummary': 'Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms', 'detailedDescription': 'The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:\n\n(i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food.\n* Age 1 month-18 yrs\n* Elimination diet was done at least 7 days before starting the study\n* Written informed consent was obtained from the parents of each child enrolled in the study\n\nExclusion Criteria:\n\n* Who have dermographism\n* Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease\n* Pregnant women\n* Who have severe eczema\n* Who receive antihistamine, topical steroid and systemic steroid \\> 20 mg/day withiin 7 days prior study'}, 'identificationModule': {'nctId': 'NCT01164293', 'acronym': 'APT', 'briefTitle': 'Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms', 'orgStudyIdInfo': {'id': '079/2553(EC1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atopy patch test', 'description': "Atopy patches were applied on food allergy patient's back for 48 hrs then the patches were removed. Reaction was evaluated at 48 and 72 hrs after applying atopy patch test", 'interventionNames': ['Device: Atopy patch test with food allergen']}], 'interventions': [{'name': 'Atopy patch test with food allergen', 'type': 'DEVICE', 'otherNames': ['Fin chamber'], 'description': 'Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate the reaction one day later (72 hr after applying atopy patch test)', 'armGroupLabels': ['Atopy patch test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Pediatrics, Siriraj hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Nualanong Visitsunthorn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nualanong Visitsunthorn', 'investigatorAffiliation': 'Mahidol University'}}}}