Peanut AllergiesNCT07775430
Flow CAST® Peanut Trial
An observational study of Peanut Allergies, run by Bühlmann Laboratories AG.
Trial summary
This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergies
- What is being tested?
- Basophil activation test
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult subjects and pediatric subjects of at least 6 months of age are eligible for study enrollment.
Who may be able to join
- Individual undergoing a blood draw
- Individual willing and able to provide two additional tubes of blood (3ml each tube) for research purposes
- Individual or legal guardian will and able to sign the informed consent form to participate in the study
Who cannot join
- Individual has undergone immunotherapy for peanuts or other identified allergens that have been shown to cause allergic symptoms
- Individual has been exposed to systemically administered glucocorticoids within the last 24 hours.
- Individual has been recently exposed to small molecule immunosuppressive medications
- Individual has been recently exposed to treatment with biologics interfering with the type-I allergic pathway
- Individual is currently involved in another "allergy treatment related" clinical research study
About this study
Official title: Clinical Evaluation of Flow CAST® as an Aid in the Diagnosis of Peanut Allergy
This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.
Read the detailed description
Study subjects will be enrolled into one of the following 3 groups: healthy non-atopic subjects with no history of allergies, atopic subjects with confirmed peanut allergy, atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy.
Subgroup analysis will be performed for each of the above categories.
- Conditions
- Peanut Allergies
- Being tested
- Basophil activation test
- Keywords
- Food allergy, peanut allergy, allergy, peanut
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basophil activation testDiagnostic test
Flow CAST® is a flow cytometry-based basophil activation test. Whole blood samples from patients are stimulated with specific allergens, as well as stimulation buffer and stimulation controls, to evaluate the patient's basophil degranulation in vitro
| Study group | Role | What they receive |
|---|---|---|
| Non-atopic | Healthy non-atopic subjects with no history of allergies Receives: Diagnostic Test: Basophil activation test | |
| Atopic peanut | Atopic subjects with confirmed peanut allergy Receives: Diagnostic Test: Basophil activation test | |
| Atopic non-peanut | Atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy Receives: Diagnostic Test: Basophil activation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy
Measured: Within 48 hours after sample collection
Clinical specificity of Flow CAST® with respect to a population of apparently healthy non-atopic subjects
Measured: Within 48 hours after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergiesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bühlmann Laboratories AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775430
- Sponsor's protocol ID
- BUHL FC F13 01
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Flow CAST® as an Aid in the Diagnosis of Peanut Allergy
- ClinicalTrials.gov ID
- NCT07775430
- Acronym / sponsor ID
- BUHL FC F13 01
- Conditions
- Peanut Allergies
- Keywords
- Food allergy, peanut allergy, allergy, peanut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Bühlmann Laboratories AGIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 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.
This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.
Detailed description
Study subjects will be enrolled into one of the following 3 groups: healthy non-atopic subjects with no history of allergies, atopic subjects with confirmed peanut allergy, atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy.
Subgroup analysis will be performed for each of the above categories.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-atopic | – | Diagnostic Test: Basophil activation testHealthy non-atopic subjects with no history of allergies |
| Atopic peanut | – | Diagnostic Test: Basophil activation testAtopic subjects with confirmed peanut allergy |
| Atopic non-peanut | – | Diagnostic Test: Basophil activation testAtopic subjects with a diagnosed allergy but confirmed negative for peanut allergy |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult subjects and pediatric subjects of at least 6 months of age are eligible for study enrollment.
Key inclusion criteria (3 listed)
- Individual undergoing a blood draw
- Individual willing and able to provide two additional tubes of blood (3ml each tube) for research purposes
- Individual or legal guardian will and able to sign the informed consent form to participate in the study
Key exclusion criteria (5 listed)
- Individual has undergone immunotherapy for peanuts or other identified allergens that have been shown to cause allergic symptoms
- Individual has been exposed to systemically administered glucocorticoids within the last 24 hours.
- Individual has been recently exposed to small molecule immunosuppressive medications
- Individual has been recently exposed to treatment with biologics interfering with the type-I allergic pathway
- Individual is currently involved in another "allergy treatment related" clinical research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basophil activation testFlow CAST® is a flow cytometry-based basophil activation test. Whole blood samples from patients are stimulated with specific allergens, as well as stimulation buffer and stimulation controls, to evaluate the patient's basophil degranulation in vitro | Diagnostic test | Atopic non-peanut, Atopic peanut, Non-atopic |
Primary outcome
Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy
Time frame: Within 48 hours after sample collection
Clinical specificity of Flow CAST® with respect to a population of apparently healthy non-atopic subjects
Time frame: Within 48 hours after sample collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Peanut Allergies
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergies, run by Bühlmann Laboratories AG.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy (time frame: Within 48 hours after sample collection). The study lists 2 primary outcomes in all. 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 20 Aug 2026.