Basophil Activation Test to Diagnose Food Allergy (NCT03309488) | Clinical Trial Compass
UnknownNot Applicable
Basophil Activation Test to Diagnose Food Allergy
United Kingdom600 participantsStarted 2018-01-30
Plain-language summary
The BAT II Study is a cross-sectional diagnostic study in which children with suspected IgE-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a history of an immediate-type allergic reaction to a food or no history of food consumption or the presence of food-specific IgE as documented by skin prick test or serum specific IgE, will undergo a diagnostic work-up to confirm or refute the diagnosis of IgE-mediated food allergy. Participants will be prospectively recruited from specialised Paediatric Allergy clinics in London and will undergo skin prick testing (SPT), specific IgE testing to allergen extracts and allergen components, basophil activation test (BAT) and oral food challenge. The diagnostic accuracy of the BAT and of other allergy tests will be assessed against the clinical gold-standard.
Who can participate
Age range6 Months ā 16 Years
SexALL
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Inclusion criteria
ā. Children ā„6 months and \<16 years old;
ā. Suspected IgE-mediated food allergy defined by:
ā. Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;
ā. Informed consent obtained from parent or guardian and assent obtained from the child.
Exclusion criteria
ā. Clinically significant chronic illness other than atopic diseases;
ā. Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (\<90%), hypotension (ā„20% reduction in systolic blood pressure) and/or admission to intensive care;
ā. Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;
ā. Contra-indication for diagnostic food challenge, namely:
ā. Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;
What they're measuring
1
Diagnostic accuracy of the basophil activation test (for each individual food allergy)