An interventional study of Basophil activation test and quality of life questionnaire in Milk Allergy, sponsored by Odense University Hospital. Not yet recruiting. Open to participants aged 0 Weeks to 47 Months. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Diagnostic
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:
Participants who undergo usual asessment for milk allergy (that is IgE measurement in blood and oral food provocation) will be asked to
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
138 studies on the registry are indexed under Milk Hypersensitivity; 28 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 89 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Odense University Hospital is the lead sponsor of 478 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
All included children will have a BAT-analysis that will be compared with the IgE measurement
Diagnostic Test: Basophil activation test · Other: quality of life questionnaire
BAT-analysis will be performed at the same time as the IgE-analysis and before the oral food provocation
FAQLQ-PF
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.
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
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
Time frame: 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
Time frame: 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
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
A calculation of the potential economic gain by performing a BAT instead of an oral food provocation.
Time frame: from enrollment to the oral food provocation test, approximately 2-6 months
No study locations are listed for this record.
Plan to share: No — If relevant, data will be shared with colleagues
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jun 2029, 29 months later.
Of 33 interventional studies with no phase under Milk Hypersensitivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 48. This study's planned 29 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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