Children With Food AllergyNCT02008643
Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases
A study testing filling questionnary to quality of life in people with Children With Food Allergy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Children With Food Allergy
- What is being tested?
- filling questionnary to quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 861 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
- Partially or not controlled asthma during last year
- No signed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases
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.
Read the detailed description
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
- Children With Food Allergy
- Being tested
- filling questionnary to quality of life
- Keywords
- Health related quality of life, food allergy, children, chronic diseases
- Medical subject headings
- Food Hypersensitivity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filling questionnary to quality of lifeOther
filling questionnary to quality of life
| Study group | Role | What they receive |
|---|---|---|
| children with food allergy | Experimental | Chidren aged 8-18 year with food allergy Receives: Other: filling questionnary to quality of life |
| children with chronic diseases | Active comparator | Not described Receives: Other: filling questionnary to quality of life |
| witnesses | Active comparator | 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 Receives: Other: filling questionnary to quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.
12 scores concerning the 12 following dimensions:
- physical functioning
- role functioning emotional
- role functioning behavior
- role functioning physical
- bodily pain
- general behavior
- mental health
- self-esteem
- general health
- change in health
- family activities
- family cohesion
Comparison between children with food allergy and healthy children scores.
Measured: Once at inclusion
Secondary outcomes (1)
comparaison beetween all questionnary
- Comparison of the CHQ-CF 87 scores between children with food allergy and chidren with other chronic diseases.
- Comparison of the CHQ-CF 87 scores with the FAQLQ-CF (or -TF) score (global and 4 dimensions) and with the FAIM score.
- Comparison of the FAQLQ-CF (or-TF) (global and 4 dimensions) with clinical characteristics of the children with food allergy
Measured: once at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Food AllergyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 861 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa GIOVANNINI-CHAMI, PH, Principal investigator, CHU de Nice-Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008643
- Sponsor's protocol ID
- 12-AOI-07
- Status last verified
- Mar 2016
- First submitted
- 3 Dec 2013
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases
- ClinicalTrials.gov ID
- NCT02008643
- Acronym / sponsor ID
- 12-AOI-07
- Conditions
- Children With Food Allergy
- Keywords
- Health related quality of life, food allergy, children, chronic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 861 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Dec 2013 (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 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
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children with food allergy | Experimental | Other: filling questionnary to quality of lifeChidren aged 8-18 year with food allergy |
| children with chronic diseases | Active comparator | Other: filling questionnary to quality of life |
| witnesses | Active comparator | Other: filling questionnary to quality of lifeInclusion 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
- Partially or not controlled asthma during last year
- No signed consent
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 |
|---|---|---|
| filling questionnary to quality of lifefilling questionnary to quality of life | Other | children with chronic diseases, children with food allergy, witnesses |
Primary outcome
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.
Time frame: Once at inclusion
12 scores concerning the 12 following dimensions: * physical functioning * role functioning emotional * role functioning behavior * role functioning physical * bodily pain * general behavior * mental health * self-esteem * general health * change in health * family activities * family cohesion Comparison between children with food allergy and healthy children scores.
1 secondary outcome
comparaison beetween all questionnary
Time frame: once at inclusion
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 27 Jul 2016.
Related trials for Children With Food Allergy
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A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
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Oral Immunotherapy for Children With Peanut Allergy
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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.
Lisa GIOVANNINI-CHAMI, PH principal investigator
CHU de Nice-Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filling questionnary to quality of life in people with Children With Food Allergy, run by Centre Hospitalier Universitaire de Nice 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 3 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 27 Jul 2016. 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?
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores. (time frame: Once at inclusion). 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 27 Jul 2016.