Clinical trial NCT05064917: BAT Cow's Milk for the Replacement of the Food Challenge Test
Official title: Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cow Milk Allergy
Keywords: Basophil Activation test
Cow's milk
oral food challenge
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Alrijne Hospital
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Bernhoven Hospital
name: Catharina Ziekenhuis Eindhoven
name: Elkerliek Hospital
name: Erasmus Medical Center
name: Elisabeth-TweeSteden Ziekenhuis
name: Maasstadziekenhuis
name: Meander Medisch Centrum
name: OLVG
name: Spaarne Gasthuis
name: Franciscus Gasthuis
name: University Medical Center Groningen
name: UMC Utrecht
name: Viecurie Medisch Centrum voor Noord LImburg
name: Zuyderland Medisch Centrum
First posted: 2021-10-01
Enrollment: 700
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children suspected of an IgE-mediated cow's milk allergy and are eligible for a food challenge test at 2nd and 3rd line allergy centres.

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.


Eligibility criteria: 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
3. Placed on a waiting list for a hospital food challenge test
4. 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.
5. Signed informed consent parents/guardians

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).

Primary outcomes:
measure: Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
timeFrame: 3 months
Secondary outcomes:
measure: Cost-effectiveness of the BAT cow's milk
timeFrame: 1 year
measure: Food allergy Quality of life
timeFrame: Before and one month after the food challenge test
measure: Health related Quality of life
timeFrame: Before and one month after the food challenge test
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Janneke Ruinemans
state: Gelderland
Study officials:
References: