Clinical Trials Directory

Trials / Completed

CompletedNCT03265262

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
Phase
N/A
Study type
Interventional
Enrollment
116 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
0 Years – 18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTThe basophil activation test (BAT)Single sample: 5 mL of venous blood

Timeline

Start date
2017-08-04
Primary completion
2018-10-04
Completion
2018-10-04
First posted
2017-08-29
Last updated
2026-02-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03265262. Inclusion in this directory is not an endorsement.