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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05064917

Enrollment

700

Registered

2021-10-01

Start date

2021-11-01

Completion date

2025-12-01

Last updated

2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Keywords

Basophil Activation test, Cow's milk, oral food challenge

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.

Interventions

DIAGNOSTIC_TESTBlood 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk	3 months

Secondary

Measure	Time frame	Description
Cost-effectiveness of the BAT cow's milk	1 year	Cost-effectiveness of the BAT cow's milk compared to the food challenge test
Food allergy Quality of life	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	Before and one month after the food challenge test	Quality of life measured by Kidscreen-10

Countries

Netherlands

Contacts

Primary ContactJanneke Ruinemans, Dr

JRuinemans-Koerts@rijnstate.nl088-0058888

Backup ContactJoyce Emons, Dr

j.a.m.emons@erasmusmc.nl010-7036263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026