The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

Not Applicable

• Conditions: FOOD ALLERGY
• Interventions: Diagnostic Test: The basophil activation test (BAT)

• Registration Number: NCT03265262
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Last Update Submitted: 2017-08-25
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29
• Study Start: 2017-09-01
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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

Exclusion Criteria

• Patients not receiving an OFC
• Lack of social insurance
• Inability to understand the study information
• Unwilling to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children receiving OFC during a diagnost	The basophil activation test (BAT)	paediatric patients attending food allergy

Primary Outcome Measures

Name	Time	Method
BAT positive and negative predictive values as compared with OFC	2 years	BAT versus OFC

Secondary Outcome Measures

Name	Time	Method
BAT quantitative results as compared with the minimal reacting dose for OFC	2 years	BAT versus OFC

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France