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

NCT05064917 | Unknown

• 1 other identifier: NL76893.091.21
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow Milk Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk

  3 months

Secondary Outcomes (3)

• Cost-effectiveness of the BAT cow's milk

  1 year

• Food allergy Quality of life

  Before and one month after the food challenge test

• Health related Quality of life

  Before and one month after the food challenge test

Study Arms (1)

Children with suspected cow's milk allergy

Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_TEST

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

Children with suspected cow's milk allergy

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age 0-12 years
• 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
• Placed on a waiting list for a hospital food challenge test
• 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.
• Signed informed consent parents/guardians

You may not qualify if:

• Age \> 12 years
• Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
• Eosinophilic esophagitis due to a cow's milk allergy
• 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
• Systemic immunosuppressant use
• Other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).

Sponsors & Collaborators

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

Study Sites (1)

Janneke Ruinemans

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Janneke Ruinemans, Dr

CONTACT

088-0058888; JRuinemans-Koerts@rijnstate.nl

Joyce Emons, Dr

CONTACT

010-7036263; j.a.m.emons@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 1, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 3, 2022

Record last verified: 2022-05

Locations

NL (1)