Milk AllergyMilkBATNCT07900594
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
A study testing Basophil activation test and quality of life questionnaire in people with Milk Allergy, run by Odense University Hospital.
Trial summary
The goal of this clinical trial is to investigate if the basophil activation test (BAT) represents a safer, faster, and more cost-effective diagnostic modality than the state-of-the art diagnostic work-up (specifik IgE and oral food provocation test) in infants with a suspicion of milk allergy. Read more about this study
- Who is it for?
- Ages 0 weeks to 47 months
- Conditions the study is for
- Milk Allergy
- What is being tested?
- Basophil activation test and quality of life questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- 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 0 weeks to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: less than 4 years
- History of Type 1 milk allergy
- Clinically indicated for diagnostic work-up of cow's milk allergy involving blood sampling (sIgE) and scheduled in-hospital oral food challenge test d Signed informed consent from parent(s) / legal guardian(s).
Who cannot join
- Children who previously have underwent an OFC for milk
- Children who have received biological treatment or systemic steroids
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MilkBAT Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
The goal of this clinical trial is to investigate if the basophil activation test (BAT) represents a safer, faster, and more cost-effective diagnostic modality than the state-of-the art diagnostic work-up (specifik IgE and oral food provocation test) in infants with a suspicion of milk allergy.
The main questions it aims to answer are:
Read more
- If the BAT has superior diagnostic specificity compared to sIgE alone when diagnosing milk allergy
- If the BAT is able to measure the allergenicity of hydrolysates
- If implementing the BAT in the diagnostic work-up of milk allergy will be cost-effective by reducing in-hospital food challenges
- If QoL is higher after an OFC compared with before the OFC, irrespective of the outcome of the OFC
Participants who undergo usual asessment for milk allergy (that is IgE measurement in blood and oral food provocation) will be asked to
- deliver blood for BAT (extra 3 ml when blood for IgE measurement is drawn)
- The parents will be asked to fullfill a QoL questionnaire
Read the detailed description
To investigate if the BAT test is better than the specific IgE analysis for milk to predict the outcome of an oral food provocation test with milk, we need a blood test from 100 infants under assessment for milk allergy.
The blood from allergic children will also be used to investigate if BAT can measure the allergenicity of milk hydrolysates.
Finally, we will use a validated questionnaire to evaluate QoL before and after a food provocation test
- Conditions
- Milk Allergy
- Being tested
- Basophil activation test, quality of life questionnaire
- Keywords
- milk allergy, BAT, QoL
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basophil activation testDiagnostic test
BAT-analysis will be performed at the same time as the IgE-analysis and before the oral food provocation
quality of life questionnaireOther
FAQLQ-PF
| Study group | Role | What they receive |
|---|---|---|
| BAT | Experimental | All included children will have a BAT-analysis that will be compared with the IgE measurement Receives: Diagnostic Test: Basophil activation test; Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of BAT
To determine the performance of the BAT to predict the outcome of the Oral Food Challenge (reference standard) for children suspected of IgE-mediated CMA.
The Oral Food challenge is the gold standard for diagnosing food allergy. It is a dichotomous variable (positive or negative).
The sensitivity and the specificity of the BAT alone and BAT in combination with IgE will be calculated.
Measured: from enrollment to the oral food provocation test, approximately 2-6 months
Secondary outcomes (4)
The allergenicity of hydrolysate compared with Milk powder
Using blood from sensitized infants, dose-response curves from BAT using hydrolysates will be compared with dose-response curves from BAT using milk powder
Measured: from enrollment to the oral food provocation test, approximately 2-6 months
The optimal allergen concentration for BAT
Using the dose-response curve to determine if the standard manufacturer-recommended allergen concentration (22ng/ml) is the optimal for diagnosing food allergy
Measured: from enrollment to the oral food provocation test, approximately 2-6 months
QoL
The quality of life (QoL) before the OFC will be compared with the QoL after the OFC using the validated questionnaire for children with food allergy: FAQLQ-PF
Measured: from enrollment to the oral food provocation test, approximately 1-7 months
The cost of a BAT compared with the cost of an oral food provocation
A calculation of the potential economic gain by performing a BAT instead of an oral food provocation.
Measured: from enrollment to the oral food provocation test, approximately 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk AllergyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefine Gradman, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900594
- Sponsor's protocol ID
- MilkBAT
- Acronym
- MilkBAT
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If relevant, data will be shared with colleagues
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MilkBAT Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
- ClinicalTrials.gov ID
- NCT07900594
- Acronym / sponsor ID
- MilkBAT / MilkBAT
- Conditions
- Milk Allergy
- Keywords
- milk allergy, BAT, QoL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Oct 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 clinical trial is to investigate if the basophil activation test (BAT) represents a safer, faster, and more cost-effective diagnostic modality than the state-of-the art diagnostic work-up (specifik IgE and oral food provocation test) in infants with a suspicion of milk allergy.
The main questions it aims to answer are:
- If the BAT has superior diagnostic specificity compared to sIgE alone when diagnosing milk allergy
- If the BAT is able to measure the allergenicity of hydrolysates
- If implementing the BAT in the diagnostic work-up of milk allergy will be cost-effective by reducing in-hospital food challenges
- If QoL is higher after an OFC compared with before the OFC, irrespective of the outcome of the OFC
Participants who undergo usual asessment for milk allergy (that is IgE measurement in blood and oral food provocation) will be asked to
- deliver blood for BAT (extra 3 ml when blood for IgE measurement is drawn)
- The parents will be asked to fullfill a QoL questionnaire
Detailed description
To investigate if the BAT test is better than the specific IgE analysis for milk to predict the outcome of an oral food provocation test with milk, we need a blood test from 100 infants under assessment for milk allergy.
The blood from allergic children will also be used to investigate if BAT can measure the allergenicity of milk hydrolysates.
Finally, we will use a validated questionnaire to evaluate QoL before and after a food provocation test
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT | Experimental | Diagnostic Test: Basophil activation test, Other: quality of life questionnaireAll included children will have a BAT-analysis that will be compared with the IgE measurement |
Who may qualify
- Ages
- 0 weeks to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: less than 4 years
- History of Type 1 milk allergy
- Clinically indicated for diagnostic work-up of cow's milk allergy involving blood sampling (sIgE) and scheduled in-hospital oral food challenge test d Signed informed consent from parent(s) / legal guardian(s).
Key exclusion criteria (2 listed)
- Children who previously have underwent an OFC for milk
- Children who have received biological treatment or systemic steroids
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 testBAT-analysis will be performed at the same time as the IgE-analysis and before the oral food provocation | Diagnostic test | BAT |
| quality of life questionnaireFAQLQ-PF | Other | BAT |
Primary outcome
The sensitivity and specificity of BAT
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
To determine the performance of the BAT to predict the outcome of the Oral Food Challenge (reference standard) for children suspected of IgE-mediated CMA. The Oral Food challenge is the gold standard for diagnosing food allergy. It is a dichotomous variable (positive or negative). The sensitivity and the specificity of the BAT alone and BAT in combination with IgE will be calculated.
4 secondary outcomes
The allergenicity of hydrolysate compared with Milk powder
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
The optimal allergen concentration for BAT
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
QoL
Time frame: from enrollment to the oral food provocation test, approximately 1-7 months
The cost of a BAT compared with the cost of an oral food provocation
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
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 28 Oct 2026.
- Individual participant dataSharing planned: No. If relevant, data will be shared with colleagues
Related trials for Milk Allergy
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A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
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TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Basophil activation test and quality of life questionnaire in people with Milk Allergy, run by Odense University Hospital.
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 2 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 28 Oct 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?
Contact Josefine Gradman, MD, PhD (+45 24608127, josefine.gradman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of BAT (time frame: from enrollment to the oral food provocation test, approximately 2-6 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 28 Oct 2026.