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

August 25, 2017 updated by: Assistance Publique Hopitaux De Marseille

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children receiving OFC during a diagnost
paediatric patients attending food allergy
Diagnostic test: The basophil activation test (BAT)
Single sample: 5 mL of venous blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BAT positive and negative predictive values as compared with OFC
Time Frame: 2 years
BAT versus OFC
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BAT quantitative results as compared with the minimal reacting dose for OFC
Time Frame: 2 years
BAT versus OFC
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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