The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.
Children aged 6 months to 15 years requiring an oral food challenge to one of the study foods (milk, egg, peanut, sesame or cashew nut) will be invited to participate in the study. Eleven centres across the UK will be recruiting participants and perforning clinical procedures, such as skin prick testing and oral food challenges (OFC), as per standard clinical care. Participants will be randomised 4:5 to either have the standard-of-care, i.e. oral food challenge to the suspected food, or take BAT (MAT if BAT inconclusive) into account to decide whether or not OFC will be required: if BAT/MAT is positive, food allergy will be confirmed without doing OFC; if BAT/MAT is negative, participants in the biomarker arm will undergo OFC. The primary outcome is the proportion of positive OFC in the biomarker arm compared with the standard-of-care arm. Secondary outcomes are: number of OFC, quality of life, anxiety and costs associated with the diagnostic work-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
398
Basophils and mast cells are the key drivers of food allergic reactions and anaphylaxis to foods. The study team have developed new tests that measure the reaction of mast cells and basophils by flow cytometry following stimulation with allergen, the BAT and the MAT: • BAT uses fresh whole blood from patients added to allergen and antibodies in a test tube. The tube containing the allergic cells are then analysed one by one to estimate how many and how much express activation markers on their surface, CD63 and CD203c. MAT uses a human mast cell line (LAD2 cells) which are human mast cells grown in the laboratory to which patients' plasma is added in order to mimic the patients' own mast cells. Sensitised LAD2 cells are then stimulated with allergen or controls and analysed by flow cytometry to assess the expression of the activation marker CD63 on the cell surface, similar to what happens in the BAT. Results of MAT will be considered only in cases of non-responding basophils.
Consumption of the food suspected of causing an allergic reaction in a medically supervised environment, starting with small amounts and progressively increasing the dose at regular intervals up to a cumulative dose corresponding to an age-appropriate portion of the food.
Sandwell and West Birmingham Hospital
Birmingham, United Kingdom
RECRUITINGAddenbrookes Hospital
Cambridge, United Kingdom
NOT_YET_RECRUITINGRoyal Hospital for Children and Young People
Edinburgh, United Kingdom
NOT_YET_RECRUITINGLeicester Royal Infirmary
Leicester, United Kingdom
RECRUITINGEvelina London Children's Hospital
London, United Kingdom
RECRUITINGKing's College Hospital
London, United Kingdom
NOT_YET_RECRUITINGUniversity College London Hospital
London, United Kingdom
NOT_YET_RECRUITINGRoyal Manchester Children's Hospital
Manchester, United Kingdom
NOT_YET_RECRUITINGGreat North Children's Hospital
Newcastle, United Kingdom
NOT_YET_RECRUITINGSheffield Children's Hospital
Sheffield, United Kingdom
NOT_YET_RECRUITING...and 1 more locations
The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.
Time frame: Up to 1 year
Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.
Time frame: Up to 1 year
The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.
Change in quality of life score at the start and end of diagnostic work-up.
Time frame: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
Change in anxiety score before and after diagnostic work-up.
Time frame: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
Change in anxiety score before and after diagnostic work-up.
Time frame: Up to 1.5 years
NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.
Time frame: Up to 1.5 years
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