BAT Cow's Milk for the Replacement of the Food Challenge Test
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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||N/A - 12 Years|
Inclusion Criteria:1. Age 0-12 years. 2. 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.
Exclusion Criteria:1. Age > 12 years. 2. Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES) 3. Eosinophilic esophagitis due to a cow's milk allergy. 4. 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. 5. Systemic immunosuppressant use. 6. Other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Cow Milk Allergy|
: Children with suspected cow's milk allergy
Diagnostic Test: - Blood draw
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
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Arnhem, Gelderland, 6815 AD
Janneke Ruinemans, Dr.