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CompletedNCT07596303Updated Jul 17, 2026

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

An observational study in Allergy Testing, Peanut Allergies and Venom Allergy, sponsored by Bühlmann Laboratories AG. Completed at 1 site in Germany. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Bühlmann Laboratories AG · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
38
Ages
18 Months and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergy Testing
  • Peanut Allergies
  • Venom Allergy
  • House Dust Mite Allergy
  • Hazelnut Allergy
  • Cat Epithelium Allergy
03

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 38 is below the median of 220 across 30 observational studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Bühlmann Laboratories AG is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be invited during a routine diagnostic visit to the Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein to contribute to the study by giving one additional sample tube. This extra sample will be collected alongside the venous blood samples already being taken as part of their standard care.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals with diagnosis of a / allergy to one of the 6 allergens, established according to common clinical practice

Exclusion criteria

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 form in German
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
38 participants (actual)
Patient registry
No

Groups and cohorts

  • Allergy / hypersensitivity to the 6 allergens

    10 patients, each with an allergy / hypersensitivity to the following allergens: (i) Peanut, (ii) Hazelnut, (iii) Honey Bee, (iv) Yellow Jacket Venom, (v) House Dust Mite (HDM) (vi) Cat Epithelium. No additional non-allergic control subjects will be recruited specifically for this study. Participants with a clinically confirmed hypersensitivity to one of the six investigated allergens will serve as allergen-specific controls for the remaining allergens for which they have no known hypersensitivity.

06

What researchers measure

Primary outcomes

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

    To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT using fresh whole blood samples from clinically characterized allergic individuals (mainly using patient's history, skin prick test, detection of sIgE, basophil activation test or provocation test).

    Time frame: From enrollment to the end of study at 4 months

Secondary outcomes

  1. Verification of agreement between tested BAT and the Certified BÜHLMANN Flow CAST® Basophil Activation Test

    Time frame: From enrollment to the end of study at 4 months

07

Study locations

1 site
  • Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar,
    München, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07596303
Lead sponsor
Bühlmann Laboratories AG
Collaborators
Technical University Munchen
Responsible party
Sponsor
First posted
May 19, 2026
Start date
May 15, 2026
Primary completion
Jun 25, 2026
Completion
Jun 25, 2026
Last update
Jul 17, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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