RecruitingNot Applicable

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

Germany60 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range

18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice Exclusion Criteria: * Pregnant women * Children under the age of 18 months * Individuals under therapy with Omalizumab or Rituximab * Individuals with an allergic reaction less than two weeks before blood sample collection * Individuals under therapy with BTK inhibitors * Individuals receiving allergen specific immunotherapy (ASIT) * Subjects with active infection and inflammatory conditions * Patients who are unable to understand the study information and informed consent form in German

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT

Timeframe: From enrollment to the end of study at 4 months

Trial details

NCT IDNCT07596303

SponsorBühlmann Laboratories AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Allergy Testing trials