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

Primary Purpose

Food Allergy in Children, 6 Years Old Maximum

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
completion of questionnaire
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Food Allergy in Children

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm

Arm Description

oral disorder

Outcomes

Primary Outcome Measures

Prevalence of orality disorder in children with food allergy

Secondary Outcome Measures

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
Link between food allergies and orality disorder
data will be collected by a questionnaire
Prevalence of dysphagia criteria

Full Information

First Posted
April 24, 2020
Last Updated
September 21, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04378335
Brief Title
Assessment of Orality Disorders in Children With Food Allergies
Acronym
ALLERGORAL
Official Title
Assessment of Orality Disorders in Children With Food Allergies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children, 6 Years Old Maximum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one arm
Arm Type
Experimental
Arm Description
oral disorder
Intervention Type
Other
Intervention Name(s)
completion of questionnaire
Intervention Description
parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.
Primary Outcome Measure Information:
Title
Prevalence of orality disorder in children with food allergy
Time Frame
Enrollment
Secondary Outcome Measure Information:
Title
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.
Description
All data will be collected by a questionnaire established by Angers Hospital
Time Frame
Enrollment
Title
Link between food allergies and orality disorder
Description
data will be collected by a questionnaire
Time Frame
Enrollment
Title
Prevalence of dysphagia criteria
Time Frame
Enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Orality Disorders in Children With Food Allergies

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