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

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.

Conditions

• Cow 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

Sponsors & Collaborators

• Alrijne Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Elkerliek Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Maasstadziekenhuis

  collaborator UNKNOWN

• Meander Medisch Centrum

  collaborator OTHER

• OLVG

  collaborator NETWORK

• Spaarne Gasthuis

  collaborator OTHER

• Franciscus Gasthuis

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Viecurie Medisch Centrum voor Noord LImburg

  collaborator UNKNOWN

• Zuyderland Medisch Centrum

  collaborator OTHER

• Rijnstate Hospital

  lead OTHER

Eligibility

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2025-12-01

Completion

2025-12-01

Countries

• Netherlands

Study Locations