IgE Mediated Food AllergyEducAANCT02106169
Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
A study testing Therapeutic education group in people with IgE Mediated Food Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- IgE Mediated Food Allergy
- What is being tested?
- Therapeutic education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2014to 7 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.
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.
- Conditions
- IgE Mediated Food Allergy
- Being tested
- Therapeutic education group
- Keywords
- Food allergy, Children and families, Therapeutic education, Quality of life
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education group | Experimental | 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). Receives: Behavioral: Therapeutic education group |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child FAQLQ global score
Measured: month 12
Secondary outcomes (6)
Child FAQLQ global score
Measured: month 4
Child FAQLQ global score
Measured: month 6
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
Measured: month 12
Parent FAQLQ global score
Measured: month 4
Parent FAQLQ global score
Measured: month 6
Parent FAQLQ global score
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start5 Nov 2014
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE Mediated Food AllergyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Allergology, Stallergenes laboratories, Picot-Lactalis laboratory, ALK Industries, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Chantal KARILA, MD, PhD, Principal investigator, Necker hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106169
- Sponsor's protocol ID
- 2013-A01104-41
- Acronym
- EducAA
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2014
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.
- ClinicalTrials.gov ID
- NCT02106169
- Acronym / sponsor ID
- EducAA / 2013-A01104-41
- Conditions
- IgE Mediated Food Allergy
- Keywords
- Food allergy, Children and families, Therapeutic education, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- French Society of Allergology, Stallergenes laboratories, Picot-Lactalis laboratory, ALK Industries, URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education group | Experimental | Behavioral: Therapeutic education groupAt 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). |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic education group | Behavioural | Therapeutic education group |
Primary outcome
Child FAQLQ global score
Time frame: month 12
6 secondary outcomes
Child FAQLQ global score
Time frame: month 4
Child FAQLQ global score
Time frame: month 6
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
Time frame: month 12
Parent FAQLQ global score
Time frame: month 4
Parent FAQLQ global score
Time frame: month 6
Parent FAQLQ global score
Time frame: month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal KARILA, MD, PhD principal investigator
Necker hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education group in people with IgE Mediated Food Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child FAQLQ global score (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.