Allergy TestingNCT07596303
BÜHLMANN BAT (Basophil Activation Test) in Allergy Diagnosis (Exploratory Pilot Study)
An observational study of Allergy Testing and Peanut Allergies, run by Bühlmann Laboratories AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Allergy Testing, Peanut Allergies, Venom Allergy
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2026to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar,
München
About this study
Official title: Exploratory Pilot Study of BÜHLMANN Automated Basophil Activation Test as an Aid to Diagnosis of Immediate Type Allergic Disorders
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.
- Conditions
- Allergy Testing, Peanut Allergies, Venom Allergy, House Dust Mite Allergy, Hazelnut Allergy, Cat Epithelium Allergy
- Medical subject headings
- Peanut Hypersensitivity, Venom Hypersensitivity, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: From enrollment to the end of study at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 May 2026
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bühlmann Laboratories AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technical University Munchen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596303
- Sponsor's protocol ID
- BAT_ExploratoryPilotStudy2026
- Status last verified
- Jul 2026
- First submitted
- 12 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pilot Study of BÜHLMANN Automated Basophil Activation Test as an Aid to Diagnosis of Immediate Type Allergic Disorders
- ClinicalTrials.gov ID
- NCT07596303
- Acronym / sponsor ID
- BAT_ExploratoryPilotStudy2026
- Conditions
- Allergy Testing, Peanut Allergies, Venom Allergy, House Dust Mite Allergy, Hazelnut Allergy, Cat Epithelium Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bühlmann Laboratories AGIndustry (pharma, biotech, devices)
- Collaborators
- Technical University Munchen
- Study start
- 15 May 2026 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT
Time frame: From enrollment to the end of study at 4 months
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy Testing and Peanut Allergies, run by Bühlmann Laboratories AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT (time frame: From enrollment to the end of study at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.