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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cow Milk Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with suspected cow's milk allergy

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No