Food Allergy in ChildrenNCT04407104
Allergy to Almond in Children
An observational study of Food Allergy in Children, run by Central Hospital, Nancy, France.
Trial summary
Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- skin prick-test
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2020to 7 Sep 2020
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: children sensitized to almond and challenged in our unit
Who may be able to join
- oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020
Who cannot join
- doubtful or incomplete oral food challenge to almond
About this study
Official title: Allergy to Almond in Children: Diagnostic Values and Severity
Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.
Read the detailed description
Secondary objectives are
- description of allergic reactions to almond (symptoms, severity)
- modelisation of eliciting dose to almond in our population
- evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond
- evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization
- Conditions
- Food Allergy in Children
- Being tested
- skin prick-test
- Keywords
- almond, tree nuts, atopy, allergy, children
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin prick-testDiagnostic test
Also called specific IgE, oral food challenge
retrospective study on data already collected
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic values of skin prick-test and sIgE to almond
Measured: BASELINE
Secondary outcomes (3)
allergic reactions during oral food challenge
symptoms and severity
Measured: BASELINE
eliciting doses to almond
ED05, ED10 and ED50
Measured: BASELINE
atopic comorbidities
respiratory allergies, other food allergies, asthma
Measured: BASELINE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 Jul 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion7 Sep 2020 (estimated)
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407104
- Sponsor's protocol ID
- 2020PI100
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy to Almond in Children: Diagnostic Values and Severity
- ClinicalTrials.gov ID
- NCT04407104
- Acronym / sponsor ID
- 2020PI100
- Conditions
- Food Allergy in Children
- Keywords
- almond, tree nuts, atopy, allergy, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 7 Sep 2020 (estimated)
- First posted
- 29 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.
Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.
Detailed description
Secondary objectives are
- description of allergic reactions to almond (symptoms, severity)
- modelisation of eliciting dose to almond in our population
- evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond
- evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children sensitized to almond and challenged in our unit
Key inclusion criteria (1 listed)
- oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020
Key exclusion criteria (1 listed)
- doubtful or incomplete oral food challenge to almond
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 |
|---|---|---|
| skin prick-testAlso: specific IgE, oral food challengeretrospective study on data already collected | Diagnostic test | – |
Primary outcome
diagnostic values of skin prick-test and sIgE to almond
Time frame: BASELINE
3 secondary outcomes
allergic reactions during oral food challenge
Time frame: BASELINE
eliciting doses to almond
Time frame: BASELINE
atopic comorbidities
Time frame: BASELINE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by Central Hospital, Nancy, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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?
Results are not available in the source record.
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?
diagnostic values of skin prick-test and sIgE to almond (time frame: BASELINE). 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 21 Jul 2020.