BAT Impact Study
Research type
Research Study
Full title
Randomised Controlled Multicentre Trial on the Clinical Impact of the Basophil Activation Test and the Mast Cell Activation Test as Food Allergy Biomarkers in Children and Young People
IRAS ID
299511
Contact name
Alexandra Santos
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The symptoms of food allergy (FA) result from the release of certain substances by cells of the immune system, called mast cells and basophils, triggered by the interaction between allergy antibodies and food allergens. FA is often diagnosed using skin prick test or by detecting IgE (allergy antibodies) in the blood. However, there are limitations to the usefulness of these tests particularly in young children as they do not always accurately predict whether a child is truly allergic to a particular allergen. Therefore, an oral food challenge (OFC) is often required, which consists of giving the patient the suspected food in a controlled environment to see whether the patient develops an allergic reaction. OFC are expensive, time-consuming and place the patient at risk of a potentially severe reaction, but this is currently the gold-standard for the diagnosis of FA. As part of her MRC-funded PhD project, Dr Alexandra Santos developed a new blood test called the basophil activation test (BAT) that works like an OFC in a test tube. This blood test showed 97% accuracy in the diagnosis of peanut allergy and reduced the need for OFC by two-thirds. In the BAT II study (ongoing), similar diagnostic tests were developed for cow's milk, egg, sesame and cashew allergies. For this study, we will be working with 11 hospital sites across the UK to further investigate the accuracy and potential impact that the BAT could have on allergy testing. Half of the study participants will follow the current standard-of-care and undergo OFC, for the other half we will take BAT into consideration and participants will only have an OFC if the BAT is negative. We anticipate that BAT will lead to a significant improvement in care for allergic patients and will reduce the costs and anxiety associated with OFC.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0903
Date of REC Opinion
19 Dec 2022
REC opinion
Favourable Opinion