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

Launched by RIJNSTATE HOSPITAL · Sep 22, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new, faster, and safer way to diagnose cow's milk allergy in children. Currently, diagnosing this allergy often involves a food challenge test, which can be expensive, time-consuming, and risky. Many families have to wait months for this test, leading to unnecessary use of special hypoallergenic formulas. The trial is studying the Basophil Activation Test (BAT), which is a quick and reliable blood test that can provide results in less than a day, without the long wait times or risks associated with the food challenge.

To participate in this trial, children aged 0 to 12 years who have symptoms suggesting a cow's milk allergy may be eligible. Symptoms could include swelling, hives, sneezing, or difficulty breathing shortly after consuming cow's milk. Participants will need to provide blood samples, and their parents or guardians will need to give consent. This study aims to improve the way cow's milk allergy is diagnosed, potentially reducing costs and improving the quality of life for families dealing with this allergy.

Gender

ALL

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).