Food AllergyNCT01480427
Assessment of Quality of Life in Food Allergic Children
An observational study of Food Allergy, run by Jacqueline Wassenberg.
Trial summary
The purpose of this study is 1. To validate in french quality of life questionnaires for food allergic children 2. To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition 3. To validate a didactic game for food allergic children Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Food Allergy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Aug 2010
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: General population of children 0-12 years old
Who may be able to join
- French speaking children with confirmed IgE mediated food allergy
- Aged 0-12 years old
- Chronic severe diseases
Who cannot join
None listed.
About this study
The purpose of this study is
- To validate in french quality of life questionnaires for food allergic children
- To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition
- To validate a didactic game for food allergic children
- Conditions
- Food Allergy
- Keywords
- Children aged 0-12 years, IgE mediated food allergy
- Medical subject headings
- Food Hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacqueline Wassenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacqueline Wassenberg, University of Lausanne Hospitals
- Investigators
- Jacqueline Wassenberg, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480427
- Sponsor's protocol ID
- PedQLFA1
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
Publications
Wassenberg J, Cochard MM, Dunngalvin A, Ballabeni P, Flokstra-de Blok BM, Newman CJ, Hofer M, Eigenmann PA. Parent perceived quality of life is age-dependent in children with food allergy. Pediatr Allergy Immunol. 2012 Aug;23(5):412-9. doi: 10.1111/j.1399-3038.2012.01310.x. Epub 2012 May 3.
PubMed 22554401
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Food Allergic Children
- ClinicalTrials.gov ID
- NCT01480427
- Acronym / sponsor ID
- PedQLFA1
- Conditions
- Food Allergy
- Keywords
- Children aged 0-12 years, IgE mediated food allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jacqueline WassenbergUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Nov 2011 (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 this study is
- To validate in french quality of life questionnaires for food allergic children
- To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition
- To validate a didactic game for food allergic children
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- General population of children 0-12 years old
Key inclusion criteria (3 listed)
- French speaking children with confirmed IgE mediated food allergy
- Aged 0-12 years old
- Chronic severe diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 Nov 2011.
- Derived from this study: PubMed 22554401Wassenberg J, Cochard MM, Dunngalvin A, Ballabeni P, Flokstra-de Blok BM, Newman CJ, Hofer M, Eigenmann PA. Parent perceived quality of life is age-dependent in children with food allergy. Pediatr Allergy Immunol. 2012 Aug;23(5):412-9. doi: 10.1111/j.1399-3038.2012.01310.x. Epub 2012 May 3.
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Recruiting
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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.
Jacqueline Wassenberg, MD principal investigator
University of Lausanne Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Jacqueline Wassenberg.
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 3 inclusion and 0 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 28 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480427, which also lists 1 linked publication.
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 28 Nov 2011.