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CompletedNCT02106169EducAAUpdated Apr 8, 2026

Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated

An interventional study of Therapeutic education group in IgE Mediated Food Allergy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study summary

The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.

This study also show us if therapeutic education has an effect on the quality of life of child's family.

Read the detailed description

Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy.

Food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management.

The impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy.

Our hypothesis is the quality of life can be improved by therapeutic education.

02

Conditions studied

  • IgE Mediated Food Allergy

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Keywords

  • Food allergy
  • Children and families
  • Therapeutic education
  • Quality of life
03

In context

Food Hypersensitivity

340 studies on the registry are indexed under Food Hypersensitivity; 85 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 211 interventional studies indexed under Food Hypersensitivity.

Browse Food Hypersensitivity studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

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

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • IgE mediated food allergy
  • Child from 8 to 12 years old (included)
  • Family who can have an internet access
  • Children which parents have received study's information
  • Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).
  • Patients who have a medical insurance.

Exclusion criteria

Exclusion Criteria:

  • Non IgE mediated food allergy
  • Child with chronic disease, except asthma and atopic dermatitis
  • Patients who already had a therapeutic education for food allergy
  • Patient already included in another study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Therapeutic education group

    At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the doctors offer patients randomized to therapeutic education to have a therapeutic education before the 4th month. The sessions will be led by a multidisciplinary equip. Each child and his family will have a therapeutic session (2 times 2 hours).

    Behavioral: Therapeutic education group

  • No intervention
    Control group

    At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the patients randomized in this group will have the habitual medical care.

Interventions

  • BehavioralTherapeutic education group
06

What researchers measure

Primary outcomes

  1. Child FAQLQ global score

    Time frame: month 12

Secondary outcomes

  1. Child FAQLQ global score

    Time frame: month 4

  2. Child FAQLQ global score

    Time frame: month 6

  3. All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions

    Time frame: month 12

  4. Parent FAQLQ global score

    Time frame: month 4

  5. Parent FAQLQ global score

    Time frame: month 6

  6. Parent FAQLQ global score

    Time frame: month 12

07

Study locations

1 site
  • Necker hospital
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02106169
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Society of Allergology, Stallergenes laboratories, Picot-Lactalis laboratory, ALK Industries, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Apr 8, 2014
Start date
Nov 5, 2014
Primary completion
Oct 7, 2016
Completion
Oct 7, 2016
Last update
Apr 8, 2026

Study contacts

Chantal KARILA, MD, PhD
principal investigator · Necker hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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