BAT Cow's Milk for the Replacement of the Food Challenge Test

Study Overview
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Brief Summary
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The prevalence of children suspected of a cow's milk allergy is 17% in the Netherlands. Cow's milk diagnosis is based on a food challenge test However, this food challenge test is expensive, time consuming, risky, with waiting lists of several months. This waiting time results in unnecessarily long-term use of expensive hypoallergenic milk formula Therefore, there is a great need to introduce a better and faster diagnostic test for cow's milk allergy diagnosis in standard care. The in vitro Basophil Activation Test (BAT) is cheap, quick (result < 1 day, no waiting list), safe for the child and is a reliable alternative for the food challenge test to diagnose an IgE-mediated allergy. A diagnostic work-up with the BAT is expected to achieve a relevant reduction in the number of expensive and risky food challenges and the prescription of hypoallergenic formula. The reduction in diagnostic delay will increase quality of life. Objective: Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test by the Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow's milk allergy in children.

Official Title
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Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Diagnostic Test: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0-12 years Suspected of cow's milk allergy with one or more of the following complaints after intake of cow's milk: angioedema urticaria sneezing and rhinitis <2 hours after feeding sensation of swelling in the throat and/or difficulty swallowing <2 hours after feeding voice change/hoarseness <2 hours after feeding cough <2 hours after feeding wheezing and/or shortness of breath <2 hours after feeding loss of consciousness <2 hours after feeding vomiting or abdominal pain or diarrhoea <2 hours after feeding in children <4 years only in combination with IgE-mediated complaints in other tracts Placed on a waiting list for a hospital food challenge test Blood draw for cow's milk sIgE and BAT < 3 months before the food challenge test. This blood draw will be simultaneously scheduled with a blood draw for regular diagnostics. Signed informed consent parents/guardians Exclusion Criteria: Age > 12 years Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES) Eosinophilic esophagitis due to a cow's milk allergy Suspected cow's milk allergy <4 years with crying and/or agitation and/or eczema and/or abdominal pain and/or failure to thrive and/or blood loss per anum and/or diarrhoea and/or reflux and/or vomiting as the only manifestation of the allergy without IgE-mediated symptoms in another organ system Systemic immunosuppressant use Other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with suspected cow's milk allergy<br> | Diagnostic Test: Blood draw<br>* The burden for child/parents in this study is low as it is limited to a single blood draw, which is already necessary for usual diagnostic care in about 70% of the children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of the BAT cow's milk | Cost-effectiveness of the BAT cow's milk compared to the food challenge test | 1 year | 
| Food allergy Quality of life | Quality of life measured by The Food Allergy Quality of Life Questionnaire (FAQLQ-CF) | Before and one month after the food challenge test | 
| Health related Quality of life | Quality of life measured by Kidscreen-10 | Before and one month after the food challenge test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basophil Activation test, Cow's milk, oral food challenge