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NCT04378335 Clinical Trial

Assessment of Orality Disorders in Children With Food Allergies

Food Allergy in Children Clinical Trial

— ALLERGORAL  

Official title:
Assessment of Orality Disorders in Children With Food Allergies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04378335
Other study ID # 49RC19_0256
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2020
Est. completion date April 20, 2023

Study information
Verified date April 2020
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders. The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 20, 2023
Est. primary completion date April 20, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 6 Years
Eligibility Inclusion Criteria: - 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 - obtention of informed consent Exclusion Criteria: - Child with allergy other than food - poor understanding of french

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• completion of questionnaire
parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.

Locations
Country Name City State
France CHU Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of orality disorder in children with food allergy Enrollment
Secondary 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. All data will be collected by a questionnaire established by Angers Hospital Enrollment
Secondary Link between food allergies and orality disorder data will be collected by a questionnaire Enrollment
Secondary Prevalence of dysphagia criteria Enrollment
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