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CompletedNCT04378335ALLERGORALUpdated Sep 22, 2023

Assessment of Orality Disorders in Children With Food Allergies

An interventional study of completion of questionnaire in Food Allergy in Children and 6 Years Old Maximum, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Months to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Food Allergy in Children
  • 6 Years Old Maximum
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 150 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Child with allergy other than food
  • poor understanding of french
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    one arm

    oral disorder

    Other: completion of questionnaire

Interventions

  • Othercompletion of questionnaire

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

06

What researchers measure

Primary outcomes

  1. Prevalence of orality disorder in children with food allergy

    Time frame: Enrollment

Secondary outcomes

  1. 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

    Time frame: Enrollment

  2. Link between food allergies and orality disorder

    data will be collected by a questionnaire

    Time frame: Enrollment

  3. Prevalence of dysphagia criteria

    Time frame: Enrollment

07

Study locations

1 site
  • CHU Angers
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04378335
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
May 7, 2020
Start date
Oct 21, 2020
Primary completion
Apr 20, 2023
Completion
Apr 20, 2023
Last update
Sep 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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