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Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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).
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-04-22
Completion Date
2029-12-30
Last Updated
2024-05-16
Healthy Volunteers
No
Conditions
Interventions
Implementation of cow's milk in decreasingly heated forms
Implementation of cow's milk in decreasingly heated forms in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.
Implementation of heated cow's milk
Implementation of heated cow's milk in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.
No intervention
Healthy subjects undergo no intervention.
Locations (5)
Imelda Hospital Bonheiden
Bonheiden, Belgium
AZ Sint-Jan
Bruges, Belgium
AZ Maria Middelares
Ghent, Belgium
Jessa Hospital
Hasselt, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium