Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.

MilkBAT Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07900594

Acronym

MilkBAT

Enrollment

100

Registered

2026-10-28

Start date

2027-01-01

Completion date

2029-12-31

Last updated

2026-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Milk Allergy

Keywords

milk allergy, BAT, QoL

Brief 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. The main questions it aims to answer are: 1. If the BAT has superior diagnostic specificity compared to sIgE alone when diagnosing milk allergy 2. If the BAT is able to measure the allergenicity of hydrolysates 3. If implementing the BAT in the diagnostic work-up of milk allergy will be cost-effective by reducing in-hospital food challenges 4. 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 1. deliver blood for BAT (extra 3 ml when blood for IgE measurement is drawn) 2. 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

Interventions

DIAGNOSTIC_TESTBasophil activation test

BAT-analysis will be performed at the same time as the IgE-analysis and before the oral food provocation

OTHERquality of life questionnaire

FAQLQ-PF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Weeks to 47 Months

Healthy volunteers

Inclusion criteria

1. Age: less than 4 years 2. History of Type 1 milk allergy 3. 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).

Exclusion criteria

1. Children who previously have underwent an OFC for milk 2. Children who have received biological treatment or systemic steroids

Design outcomes

Primary

Measure	Time frame	Description
The sensitivity and specificity of BAT	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.

Secondary

Measure	Time frame	Description
The allergenicity of hydrolysate compared with Milk powder	from enrollment to the oral food provocation test, approximately 2-6 months	Using blood from sensitized infants, dose-response curves from BAT using hydrolysates will be compared with dose-response curves from BAT using milk powder
The optimal allergen concentration for BAT	from enrollment to the oral food provocation test, approximately 2-6 months	Using the dose-response curve to determine if the standard manufacturer-recommended allergen concentration (22ng/ml) is the optimal for diagnosing food allergy
QoL	from enrollment to the oral food provocation test, approximately 1-7 months	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
The cost of a BAT compared with the cost of an oral food provocation	from enrollment to the oral food provocation test, approximately 2-6 months	A calculation of the potential economic gain by performing a BAT instead of an oral food provocation.

Contacts

CONTACTJosefine Gradman, MD, PhD

josefine.gradman@rsyd.dk+45 24608127

CONTACTJane Clemensen, Professor

jane.clemensen@rsyd.dk+45 24342024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 29, 2026