An interventional study of Basophil activation test (BAT) and Oral food challenge (OFC) in Food Allergy, Food Allergy in Infants and Food Allergy in Children, sponsored by King's College London. Recruiting at 11 sites in United Kingdom. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by King's College London · Not applicable, Interventional, and Diagnostic
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 398 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as:
Exclusion Criteria:
for diagnostic food challenge, namely:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will have blood taken to test for BAT/MAT. Participants with a positive BAT/MAT will dispense from oral food challenge (OFC). Participants with negative or inconclusive BAT/MAT will undergo OFC.
Diagnostic Test: Basophil activation test (BAT) · Diagnostic Test: Oral food challenge (OFC)
All participants in the standard-of-care arm will have blood taken to test for BAT/MAT. Regardless of the result of BAT/MAT, all participants in this arm will undergo an oral food challenge, as per the current standard-of-care.
Diagnostic Test: Basophil activation test (BAT) · Diagnostic Test: Oral food challenge (OFC)
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.
Also known as: Mast cell activation test (MAT)
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.
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
Plan to share: No
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