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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03265262

Enrollment

116

Registered

2017-08-29

Start date

2017-08-04

Completion date

2018-10-04

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FOOD ALLERGY

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

Interventions

DIAGNOSTIC_TESTThe basophil activation test (BAT)

Single sample: 5 mL of venous blood

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
BAT positive and negative predictive values as compared with OFC	2 years	BAT versus OFC

Secondary

Measure	Time frame	Description
BAT quantitative results as compared with the minimal reacting dose for OFC	2 years	BAT versus OFC

Countries

France

Contacts

STUDY_DIRECTORUrielle Desalbres

Assistance Publique Hopitaux De Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026