Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases

NCT ID: NCT02008643

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

861 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

* To compare generic and specific HRQL scores in children with food allergy
* Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

Generic HRQL questionnaire (CHQ-87) will be distributed :

* after hospital consultation for patients
* in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the " Food Allergy Independent Measure " will also distributed to chidren with food allergy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children With Food Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

children with food allergy

Chidren aged 8-18 year with food allergy

Group Type EXPERIMENTAL

filling questionnary to quality of life

Intervention Type OTHER

filling questionnary to quality of life

children with chronic diseases

Group Type ACTIVE_COMPARATOR

filling questionnary to quality of life

Intervention Type OTHER

filling questionnary to quality of life

witnesses

Inclusion criteria Age between 8-18 year old Children attending schools of Nice City Signed informed consent of the two parents Signed informed consent of the child Health insurance recipient

Non inclusion criteria Association with another medical or psychiatric chronic disease No signed consent

Group Type ACTIVE_COMPARATOR

filling questionnary to quality of life

Intervention Type OTHER

filling questionnary to quality of life

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

filling questionnary to quality of life

filling questionnary to quality of life

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 8-18 year old
* IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:

Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE

* Signed informed consent of the two parents
* Signed informed consent of the child
* Health insurance recipient

Exclusion Criteria

* Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
* Partially or not controlled asthma during last year
* No signed consent
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa GIOVANNINI-CHAMI, PH

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice-Lenval

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Pédiatrie

Nice, Nice, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-AOI-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Immunotherapy in Young Children With Food Allergy
NCT05738798 ENROLLING_BY_INVITATION NA
Food Oral Immunotherapy for Peanut Allergy
NCT04222491 ENROLLING_BY_INVITATION PHASE2