Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
Time Frame: 3 months
Secondary Outcomes
- Health related Quality of life(Before and one month after the food challenge test)
- Cost-effectiveness of the BAT cow's milk(1 year)
- Food allergy Quality of life(Before and one month after the food challenge test)