NCT05064917

BAT Cow's Milk for the Replacement of the Food Challenge Test

Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of children suspected of a cow's milk allergy is 17% in the Netherlands. Cow's milk diagnosis is based on a food challenge test However, this food challenge test is expensive, time consuming, risky, with waiting lists of several months. This waiting time results in unnecessarily long-term use of expensive hypoallergenic milk formula Therefore, there is a great need to introduce a better and faster diagnostic test for cow's milk allergy diagnosis in standard care. The in vitro Basophil Activation Test (BAT) is cheap, quick (result \< 1 day, no waiting list), safe for the child and is a reliable alternative for the food challenge test to diagnose an IgE-mediated allergy. A diagnostic work-up with the BAT is expected to achieve a relevant reduction in the number of expensive and risky food challenges and the prescription of hypoallergenic formula. The reduction in diagnostic delay will increase quality of life. Objective: Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test by the Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow's milk allergy in children.

Conditions

• Cow Milk Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw	The burden for child/parents in this study is low as it is limited to a single blood draw, which is already necessary for usual diagnostic care in about 70% of the children

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-10-01
• Last updated: 2022-05-03

Locations

1 site across 1 country: Netherlands