NCT03309488

Basophil Activation Test to Diagnose Food Allergy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 6 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Food Allergy
• Food Allergy in Infants
• Food Allergy in Children
• Food Allergen Sensitisation
• Milk Allergy
• Egg Allergy
• Nut Allergy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-30
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2017-10-13
• Last updated: 2020-09-02

Locations

1 site across 1 country: United Kingdom