Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-02 @ 6:20 AM
Study NCT ID:
NCT04378335
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Orality Disorders in Children With Food Allergies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of orality disorder in children with food allergy', 'timeFrame': 'Enrollment'}], 'secondaryOutcomes': [{'measure': 'Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data.', 'timeFrame': 'Enrollment', 'description': 'All data will be collected by a questionnaire established by Angers Hospital'}, {'measure': 'Link between food allergies and orality disorder', 'timeFrame': 'Enrollment', 'description': 'data will be collected by a questionnaire'}, {'measure': 'Prevalence of dysphagia criteria', 'timeFrame': 'Enrollment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Allergy in Children', '6 Years Old Maximum']}, 'descriptionModule': {'briefSummary': 'Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.\n\nThe aim is to estimate the prevalence of orality disorder for child with one or several food allergy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers\n* obtention of informed consent\n\nExclusion Criteria:\n\n* Child with allergy other than food\n* poor understanding of french'}, 'identificationModule': {'nctId': 'NCT04378335', 'acronym': 'ALLERGORAL', 'briefTitle': 'Assessment of Orality Disorders in Children With Food Allergies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Assessment of Orality Disorders in Children With Food Allergies', 'orgStudyIdInfo': {'id': '49RC19_0256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one arm', 'description': 'oral disorder', 'interventionNames': ['Other: completion of questionnaire']}], 'interventions': [{'name': 'completion of questionnaire', 'type': 'OTHER', 'description': 'parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.', 'armGroupLabels': ['one arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}