The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy
Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
1 other identifier
interventional
116
1 country
1
Brief Summary
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children. Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals. Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure. Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2017
CompletedFirst Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2018
CompletedFebruary 5, 2026
February 1, 2026
1.2 years
August 25, 2017
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
BAT positive and negative predictive values as compared with OFC
BAT versus OFC
2 years
Secondary Outcomes (1)
BAT quantitative results as compared with the minimal reacting dose for OFC
2 years
Study Arms (1)
Children receiving OFC during a diagnost
EXPERIMENTALpaediatric patients attending food allergy
Interventions
Single sample: 5 mL of venous blood
Eligibility Criteria
You may qualify if:
- Age 0 - 18 years
- Attending La Timone Paediatric Hospital for OFC
- Social insurance
- Parents and if possible child have received information and signed the consent form
You may not qualify if:
- Patients not receiving an OFC
- Lack of social insurance
- Inability to understand the study information
- Unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
Arif-Lusson R, Agabriel C, Carsin A, Cabon I, Senechal H, Poncet P, Vitte J, Busnel JM. Streamlining basophil activation testing to enable assay miniaturization and automation of sample preparation. J Immunol Methods. 2020 Jun-Jul;481-482:112793. doi: 10.1016/j.jim.2020.112793. Epub 2020 May 6.
PMID: 32387696DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle Desalbres
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 29, 2017
Study Start
August 4, 2017
Primary Completion
October 4, 2018
Study Completion
October 4, 2018
Last Updated
February 5, 2026
Record last verified: 2026-02