An observational study in Food Allergy, Food Allergy in Infants and Food Allergy in Children, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by King's College London · Observational
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.
Children seen in specialized Pediatric Allergy clinics with suspected allergy to one of the foods studied, namely milk, egg, sesame and nuts.
Suspected IgE-mediated food allergy defined by:
Exclusion Criteria:
Contra-indication for diagnostic food challenge, namely:
Patients with a positive oral challenge to the food being studied.
Diagnostic Test: Oral food challenge
Patients with a negative oral challenge to the food being studied.
Diagnostic Test: Oral food challenge
Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.
Also known as: Basophil activation test, Skin prick test, Specific IgE test
Diagnostic accuracy of the basophil activation test (for each individual food allergy)
Accuracy of %CD63+ basophils
Time frame: 3 years
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens
Accuracy of weal diameter or level of IgE
Time frame: 3 years
Association between BAT and severity of symptoms during challenges
Correlation between %CD63+ basophils and severity grade
Time frame: 3 years
Association between BAT and threshold of reactivity during challenges
Correlation between CD-sens and cumulative threshold dose
Time frame: 3 years
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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King's College London