Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-30 @ 1:45 PM
Study NCT ID:
NCT01070368
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2010-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-04-18', 'releaseDate': '2013-03-11'}], 'estimatedResultsFirstSubmitDate': '2013-03-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D021182', 'term': 'Wheat Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-27', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation skin test result and food challenge result', 'timeFrame': '3 year'}], 'secondaryOutcomes': [{'measure': 'comparison of skin test result and specific IgE to challenge result', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['skin test', 'open wheat challenge'], 'conditions': ['Wheat Allergy']}, 'descriptionModule': {'briefSummary': 'Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for wheat allergy. However, commercial wheat extracted for skin prick test have less precise test result compared to extract from omega-5 gliadin, which is one of the major allergen with immediate wheat allergy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient with the age of 1-15 year old\n* A history of symptoms that suspected of type 1 hypersensitivity (eg. Urticaria, angioedema, wheezing, anaphylaxis) occur within 4 hours after wheat ingestion.\n* Patients attend in allergy clinic, pediatric department, Siriraj hospital since 2007-2012\n\nExclusion Criteria:\n\n* First sign and symptom happens more than 4 hours since wheat ingestion\n* Have underlying disease such as heart disease, epilepsy etc.\n* Have contraindication for performed skin prick test'}, 'identificationModule': {'nctId': 'NCT01070368', 'briefTitle': 'Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study', 'orgStudyIdInfo': {'id': '231/2552(EC4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food challenge, skin test', 'description': 'Skin test by two extract commercial, and in-house extract. and open challenge with wheat (except in patient with history of wheat anaphylaxis: assume as challenge positive)', 'interventionNames': ['Other: Commercial extract and in-house wheat extract']}], 'interventions': [{'name': 'Commercial extract and in-house wheat extract', 'type': 'OTHER', 'description': 'Patients with a history of wheat allergy underwent two skin test extracts, and open challenge with wheat. A blood test for specific IgE was performed in the same time.', 'armGroupLabels': ['Food challenge, skin test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'nittida pannakapitak', 'investigatorAffiliation': 'Mahidol University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-03-11', 'type': 'RELEASE'}, {'date': '2013-04-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'nittida pannakapitak, Principal investigator, Mahidol University'}}}}