Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05340920
Status:
UNKNOWN
Last Update Posted:
2022-04-22
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relevance of Sensitization to Fenugreek in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral food challenge to fenugreek', 'timeFrame': '2017-2022', 'description': "Astier's score 0 to 4 (0=negative, 1 and 2=mild to moderate reaction, 3 and 4 = severe reaction)"}, {'measure': 'skin prick-test to fenugreek', 'timeFrame': '2017-2022', 'description': 'skin prick test positive if wheal size superior to 3mm'}, {'measure': 'specific IgE to fenugreek', 'timeFrame': '2017-2022', 'description': 'specific IgE positive if value superior to 0.35kU/L'}], 'secondaryOutcomes': [{'measure': 'severity of allergy', 'timeFrame': '2017-2022', 'description': 'reactogenic dose (from 1 to 1000mg of fenugreek)'}, {'measure': 'molecular profile for peanut allergy', 'timeFrame': '2017-2022', 'description': 'IgE values for rAra h1, h2, h3, h6, h8, h9'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allergy', 'children', 'legumes', 'sensitization', 'diagnostic'], 'conditions': ['Allergy to Fenugreek']}, 'descriptionModule': {'briefSummary': 'The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children aged from 1 to 17 years old, sensitized to fenugreek with an evaluation of their tolerance to fenugreek by an oral food challenge', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children for whom an oral food challenge to fenugreek has been performed between the 1st January 2017 and the 15th April 2022 and for whom skin prick test and/or specific IgE to fenugreek are avalaible\n\nExclusion Criteria:\n\n* patient over 18 years old\n* undeterminate oral food challenge'}, 'identificationModule': {'nctId': 'NCT05340920', 'briefTitle': 'Relevance of Sensitization to Fenugreek in Children', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Relevance of Sensitization to Fenugreek in Children', 'orgStudyIdInfo': {'id': '2021PI211'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral Food Challenge', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnostic values of skin prick test and specific IgE for allergy confirmed by oral food challenge (routine, not an intervention)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Hospitalo-Universitaire de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Amandine Divaret-Chauveau, MD', 'role': 'CONTACT', 'email': 'a.chauveau@chru-nancy.fr', 'phone': '+33 630094606'}, {'name': 'Timé Muller, MD', 'role': 'CONTACT', 'email': 't.muller@chru-nancy.fr', 'phone': '+33 630336839'}], 'overallOfficials': [{'name': 'Amandine Divaret-Chauveau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'centre hospitalo-universitaire de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of pediatric allergy department', 'investigatorFullName': 'Amandine DIVARET-CHAUVEAU', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}