Food Allergy in ChildrenALLERGORALNCT04378335
Assessment of Orality Disorders in Children With Food Allergies
A study testing completion of questionnaire in people with Food Allergy in Children and 6 Years Old Maximum, run by University Hospital, Angers at 1 site in France.
Trial summary
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders. The aim is to estimate the prevalence of orality disorder for child with one or several food allergy. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Food Allergy in Children, 6 Years Old Maximum
- What is being tested?
- completion of questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2020to 20 Apr 2023
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers
- obtention of informed consent
Who cannot join
- Child with allergy other than food
- poor understanding of french
Trial locations and contacts
1 site in 1 country.
About this study
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.
The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.
- Conditions
- Food Allergy in Children, 6 Years Old Maximum
- Being tested
- completion of questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of questionnaireOther
parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.
| Study group | Role | What they receive |
|---|---|---|
| one arm | Experimental | oral disorder Receives: Other: completion of questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of orality disorder in children with food allergy
Measured: Enrollment
Secondary outcomes (3)
Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data.
All data will be collected by a questionnaire established by Angers Hospital
Measured: Enrollment
Link between food allergies and orality disorder
data will be collected by a questionnaire
Measured: Enrollment
Prevalence of dysphagia criteria
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start21 Oct 2020
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378335
- Sponsor's protocol ID
- 49RC19_0256
- Acronym
- ALLERGORAL
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Orality Disorders in Children With Food Allergies
- ClinicalTrials.gov ID
- NCT04378335
- Acronym / sponsor ID
- ALLERGORAL / 49RC19_0256
- Conditions
- Food Allergy in Children, 6 Years Old Maximum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 7 May 2020 (actual)
- 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.
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.
The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | Experimental | Other: completion of questionnaireoral disorder |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers
- obtention of informed consent
Key exclusion criteria (2 listed)
- Child with allergy other than food
- poor understanding of french
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 |
|---|---|---|
| completion of questionnaireparents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation. | Other | one arm |
Primary outcome
Prevalence of orality disorder in children with food allergy
Time frame: Enrollment
3 secondary outcomes
Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data.
Time frame: Enrollment
Link between food allergies and orality disorder
Time frame: Enrollment
Prevalence of dysphagia criteria
Time frame: Enrollment
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 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing completion of questionnaire in people with Food Allergy in Children and 6 Years Old Maximum, run by University Hospital, Angers 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 2 inclusion and 2 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 22 Sep 2023. 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?
Prevalence of orality disorder in children with food allergy (time frame: Enrollment). 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 22 Sep 2023.