Clinical Trial

BÜHLMANN BAT (Basophil Activation Test) in Allergy Diagnosis (Exploratory Pilot Study)

Completed
View on ClinicalTrials.gov →
Summary
The goal of this exploratory pilot study is to generate early data needed for future validation studies of the automated BÜHLMANN BAT (Basophil activation test) assay. The main questions it aims to answer are: Does the BAT assay use the optimal allergen concentrations for stimulation, and how do its preliminary cut-offs perform in a real-world clinical scenario? Participants older than 1.5 years who are being evaluated for possible allergy sensitization will provide one additional blood tube during their routine blood draw as part of the regular medical care. The study involves only one visit and does not provide direct personal benefit.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-19
notable Enrollment reduced: 60 -> 38 participants 2026-07-19
notable Primary completion pushed: 2026-05 -> 2026-06-25 2026-07-19
minor Completion moved earlier: 2026-08-31 -> 2026-06-25 2026-07-19
critical Recruitment opened 2026-06-02
Trial Details
NCT Number NCT07596303
Lead Sponsor Bühlmann Laboratories AG
Collaborators: Technical University Munchen
Conditions Allergy Testing, Peanut Allergies, Venom Allergy, House Dust Mite Allergy, Hazelnut Allergy, Cat Epithelium Allergy
Enrollment 38 participants
Start Date 2026-05-15
Primary Completion 2026-06-25 (estimated)
Study Completion 2026-06-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-17