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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: FOOD ALLERGY

Treatments: Diagnostic Test: The basophil activation test (BAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03265262

2017-26

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Children receiving OFC during a diagnost

Experimental group

Description:

paediatric patients attending food allergy

Treatment:

Diagnostic Test: The basophil activation test (BAT)