Actively Recruiting

Phase Not Applicable
Age: 1Year - 18Years
All Genders
NCT06380673

Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-08

90

Participants Needed

5

Research Sites

296 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).

CONDITIONS

Official Title

Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 to 18 years with a clinical diagnosis of IgE-mediated cow's milk allergy confirmed by history and testing
  • Children at least 12 months old before starting heated cow's milk introduction
  • Children who have not had grade 4 anaphylaxis due to cow's milk ingestion
  • Children with specific IgE levels to Bos d 8 below 1.2 kU/mL and/or who passed a 20-minute cooked cow's milk provocation test
Not Eligible

You will not qualify if you...

  • Children who had grade 4 anaphylaxis due to cow's milk ingestion
  • Children younger than 12 months old at the time of passing the 20-minute cooked cow's milk oral food challenge
  • Parents unable or unwilling to follow a specific cow's milk protein diet regularly at home
  • Children with multiple food allergies incompatible with the Flemish Milk Ladder choices
  • Parents and/or children unwilling to give informed consent or assent

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Imelda Hospital Bonheiden

Bonheiden, Belgium

Actively Recruiting

2

AZ Sint-Jan

Bruges, Belgium

Actively Recruiting

3

AZ Maria Middelares

Ghent, Belgium

Actively Recruiting

4

Jessa Hospital

Hasselt, Belgium

Actively Recruiting

5

UZ Leuven Gasthuisberg

Leuven, Belgium

Actively Recruiting

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Research Team

D

Dominique MA Bullens, Prof. MD

CONTACT

M

Marleen Jannis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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