Actively Recruiting
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
Eligibility Criteria
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
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
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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