Using Basophil Activation Test to Diagnose Cow's Milk Allergy

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

This study is testing if a new blood test can quickly and safely diagnose cow's milk allergy in children, making it easier for families to manage the condition.

Quick facts

• Study type: Observational
• Enrollment: 700 (estimated)
• Ages: N/A to 12 Years
• Sex: All
• Sponsor: Rijnstate Hospital (Academic / other)
• Locations: 1 site (Arnhem, Gelderland)
• Trial ID: NCT05064917 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of the Basophil Activation Test (BAT) as a quicker and safer alternative to the traditional food challenge test for diagnosing cow's milk allergy in children. The BAT is expected to provide results in less than a day, eliminating the long waiting times and risks associated with food challenges. By assessing children aged 0-12 years who are suspected of having a cow's milk allergy, the study seeks to reduce unnecessary use of hypoallergenic formulas and improve the quality of life for affected families. Blood samples will be collected for analysis of specific IgE and BAT results.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 0-12 years who are suspected of having a cow's milk allergy and are currently on a waiting list for a food challenge test.

Not a fit: Patients who do not exhibit symptoms of cow's milk allergy or are older than 12 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly streamline the diagnostic process for cow's milk allergy, reducing costs and risks for patients.

How similar studies have performed: Other studies have shown promising results with the Basophil Activation Test as a diagnostic tool, indicating potential for success in this approach.

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).

Where this trial is running

Arnhem, Gelderland

• Janneke Ruinemans — Arnhem, Gelderland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Janneke Ruinemans, Dr

Conditions Cow Milk Allergy; Basophil Activation test; Cow's milk; oral food challenge