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OpenTrials
Completed

NCT Number: NCT03265262

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

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

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The basophil activation test (BAT)

Diagnostic Test

Single sample: 5 mL of venous blood

Primary outcomes

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

    Time frame: 2 years

    BAT versus OFC

Secondary outcomes

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

    Time frame: 2 years

    BAT versus OFC

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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