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

Overview

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.

Full Title of Study: “Basophil Activation Test (BAT) Cow’s Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2025

Interventions

  • 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

Arms, Groups and Cohorts

  • Children with suspected cow’s milk allergy

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow’s Milk
    • Time Frame: 3 months

Secondary Measures

  • Cost-effectiveness of the BAT cow’s milk
    • Time Frame: 1 year
    • Cost-effectiveness of the BAT cow’s milk compared to the food challenge test
  • Food allergy Quality of life
    • Time Frame: Before and one month after the food challenge test
    • Quality of life measured by The Food Allergy Quality of Life Questionnaire (FAQLQ-CF)
  • Health related Quality of life
    • Time Frame: Before and one month after the food challenge test
    • Quality of life measured by Kidscreen-10

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rijnstate Hospital
  • Collaborator
    • Alrijne Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Janneke Ruinemans, Dr, 088-0058888, JRuinemans-Koerts@rijnstate.nl

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