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

Cow Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064917
• Other study ID #: NL76893.091.21
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2022
• Source: Rijnstate Hospital
• Contact: Janneke Ruinemans, Dr
• Phone: 088-0058888
• Email: JRuinemans-Koerts[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cow Milk Allergy
• Milk Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Netherlands	Janneke Ruinemans	Arnhem	Gelderland

Sponsors (17)

Lead Sponsor

Collaborator

Rijnstate Hospital

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Alrijne Hospital, Bernhoven Hospital, Catharina Ziekenhuis Eindhoven, Elisabeth-TweeSteden Ziekenhuis, Elkerliek Hospital, Erasmus Medical Center, Franciscus Gasthuis, Maasstadziekenhuis, Meander Medisch Centrum, OLVG, Spaarne Gasthuis, UMC Utrecht, University Medical Center Groningen, Viecurie Medisch Centrum voor Noord LImburg, Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk		3 months
Secondary	Cost-effectiveness of the BAT cow's milk	Cost-effectiveness of the BAT cow's milk compared to the food challenge test	1 year
Secondary	Food allergy Quality of life	Quality of life measured by The Food Allergy Quality of Life Questionnaire (FAQLQ-CF)	Before and one month after the food challenge test
Secondary	Health related Quality of life	Quality of life measured by Kidscreen-10	Before and one month after the food challenge test