Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 3:33 AM
Study NCT ID:
NCT01728168
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Food Allergies to Proteins From Different Legumes
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of a sensitization to legume proteins', 'timeFrame': '20 minutes after skin prick', 'description': 'Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)'}]}, 'conditionsModule': {'keywords': ['lupin', 'peanut', 'soy', 'pea', 'legumes', 'cross-reactivity', 'sensitization', 'atopy'], 'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n * Male and female subjects\n * Age 18 up to 75 years\n * For group "Atopic": either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\\>10 points).\n2. Exclusion Criteria:\n\n * Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids\n * Acute allergic symptoms\n * Skin infections at the test side\n * Pregnancy, lactation\n * Acute inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT01728168', 'briefTitle': 'Prevalence of Food Allergies to Proteins From Different Legumes', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects', 'orgStudyIdInfo': {'id': 'LSEP H54-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atopic', 'description': 'Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\\>10 points).'}, {'label': 'Non-atopic', 'description': 'Subjects without atopy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07548', 'city': 'Gera', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'SRH Wald-Klinikum Gera gGmbH', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}], 'overallOfficials': [{'name': 'Martin Kaatz, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SRH Wald-Klinikum Gera GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'SRH Wald-Klinikum Gera GmbH', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. habil.', 'investigatorFullName': 'Gerhard Jahreis', 'investigatorAffiliation': 'University of Jena'}}}}