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

FOOD ALLERGY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03265262
• Other study ID #: 2017-26
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2017
• Last updated: August 25, 2017
• Start date: September 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Ania CARSIN
• Phone: 04.91.68.67.65
• Email: ania.carsin[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• FOOD ALLERGY
• Food Hypersensitivity
• Hypersensitivity

Intervention

Diagnostic Test:
• The basophil activation test (BAT)
Single sample: 5 mL of venous blood

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAT positive and negative predictive values as compared with OFC	BAT versus OFC	2 years
Secondary	BAT quantitative results as compared with the minimal reacting dose for OFC	BAT versus OFC	2 years