- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407104
Allergy to Almond in Children
July 20, 2020 updated by: Central Hospital, Nancy, France
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children sensitized to almond and challenged in our unit
Description
Inclusion Criteria:
- oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020
Exclusion Criteria:
- doubtful or incomplete oral food challenge to almond
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
diagnostic values of skin prick-test and sIgE to almond
Time Frame: BASELINE
|
BASELINE
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
allergic reactions during oral food challenge
Time Frame: BASELINE
|
symptoms and severity
|
BASELINE
|
|
eliciting doses to almond
Time Frame: BASELINE
|
ED05, ED10 and ED50
|
BASELINE
|
|
atopic comorbidities
Time Frame: BASELINE
|
respiratory allergies, other food allergies, asthma
|
BASELINE
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 20, 2020
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
September 7, 2020
Study Registration Dates
First Submitted
May 25, 2020
First Submitted That Met QC Criteria
May 25, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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