Assessment of Orality Disorders in Children With Food Allergies (ALLERGORAL)

September 21, 2023 updated by: University Hospital, Angers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Chu Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one arm
oral disorder
Other: completion of questionnaire
parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of orality disorder in children with food allergy
Time Frame: Enrollment
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Enrollment
All data will be collected by a questionnaire established by Angers Hospital
Enrollment
Link between food allergies and orality disorder
Time Frame: Enrollment
data will be collected by a questionnaire
Enrollment
Prevalence of dysphagia criteria
Time Frame: Enrollment
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC19_0256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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