Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT00163735
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potential Allergens in Wine: Double-blind Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D000707', 'term': 'Anaphylaxis'}, {'id': 'D016269', 'term': 'Milk Hypersensitivity'}, {'id': 'D021181', 'term': 'Egg Hypersensitivity'}, {'id': 'D021184', 'term': 'Nut Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allergic reactions to wine'}], 'secondaryOutcomes': [{'measure': 'Positive basophil activiation test to wines'}]}, 'conditionsModule': {'keywords': ['Food allergy', 'wine', 'milk allergy', 'egg allergy', 'nut allergy', 'fish allergy'], 'conditions': ['Food Allergy', 'Anaphylaxis']}, 'descriptionModule': {'briefSummary': 'This study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.', 'detailedDescription': 'Recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". However it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions.\n\nComparison:This study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of Australian commercial wines fined with food allergens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -\n\nExclusion Criteria:\n\nMajor asthma or cardiac disease Unwilling or unable to participate\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00163735', 'briefTitle': 'Potential Allergens in Wine: Double-blind Placebo-controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis', 'orgStudyIdInfo': {'id': '124/02'}, 'secondaryIdInfos': [{'id': 'Number 124/02'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of wine fined with potential food allergens', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'AIR Med, Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': "Robyn E O'Hehir, MBBS PhD FRACP", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alfred Hospital and Monash University'}, {'name': 'Jennifer M Rolland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Creina S Stockley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Australian Wine Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Australian Wine Research Institute', 'class': 'OTHER'}, {'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'The Alfred', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}