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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A - 12 Years
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05064917
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rijnstate Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Allergy

Arms & Interventions

Arms

: Children with suspected cow's milk allergy

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

Contact a Trial Team

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International Sites

Janneke Ruinemans, Arnhem, Gelderland, Netherlands

Status

Recruiting

Address

Janneke Ruinemans

Arnhem, Gelderland, 6815 AD

Site Contact

Janneke Ruinemans, Dr.

[email protected]

088 005 88888

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