Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- BAT positive and negative predictive values as compared with OFC
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Children receiving OFC during a diagnost
paediatric patients attending food allergy
Intervention: The basophil activation test (BAT) (Diagnostic Test)
Outcomes
Primary Outcomes
BAT positive and negative predictive values as compared with OFC
Time Frame: 2 years
BAT versus OFC
Secondary Outcomes
- BAT quantitative results as compared with the minimal reacting dose for OFC(2 years)