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CompletedNCT03265262Updated Feb 5, 2026

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

An interventional study of The basophil activation test (BAT) in FOOD ALLERGY, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Not applicable
Ages
0 Years to 18 Years
Sex
All
01

Study 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

02

Conditions studied

  • FOOD ALLERGY

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03

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients not receiving an OFC
  • Lack of social insurance
  • Inability to understand the study information
  • Unwilling to participate
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    Children receiving OFC during a diagnost

    paediatric patients attending food allergy

    Diagnostic Test: The basophil activation test (BAT)

Interventions

  • Diagnostic testThe basophil activation test (BAT)

    Single sample: 5 mL of venous blood

05

What researchers measure

Primary outcomes

  1. BAT positive and negative predictive values as compared with OFC

    BAT versus OFC

    Time frame: 2 years

Secondary outcomes

  1. BAT quantitative results as compared with the minimal reacting dose for OFC

    BAT versus OFC

    Time frame: 2 years

06

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
07

References and documents

Publications

  • 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. PubMed 32387696 ↗
08

Registry details

Key details

Study ID
NCT03265262
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Aug 4, 2017
Primary completion
Oct 4, 2018
Completion
Oct 4, 2018
Last update
Feb 5, 2026

Study contacts

Urielle Desalbres
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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