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

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.

Study Overview

• Status: Recruiting
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Diagnostic test: Blood draw

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Janneke Ruinemans, Dr; Phone Number: 088-0058888; Email: JRuinemans-Koerts@rijnstate.nl
• Study Contact Backup: Name: Joyce Emons, Dr; Phone Number: 010-7036263; Email: j.a.m.emons@erasmusmc.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Recruiting
      • Janneke Ruinemans
      • Contact: Janneke Ruinemans, Dr.; Phone Number: 088 005 88888; Email: JRuinemans-Koerts@rijnstate.nl
      • Contact: Eva Koffeman, Dr.; Phone Number: 088 005 8888; Email: ekoffeman@rijnstate.nl
      • Principal Investigator: Eva Koffeman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children suspected of an IgE-mediated cow's milk allergy and are eligible for a food challenge test at 2nd and 3rd line allergy centres.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with suspected cow's milk allergy	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cow's milk; Basophil Activation test; oral food challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: NL76893.091.21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No