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โ† Trials
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Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

RecruitingNAAges 1 Year - 18 YearsAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic. * Children are at least 12 months old before introduction of heated cow's milk is considered. * Children did not suffer from grade 4 anaphylaxis due to cow's milk-ingestion at presentation. * Children have specific IgE levels to Bos d 8 below 1.2 kU/mL and/or children passed 20' cooked cow's milk provocation test executed on clinical judgement. Exclusion Criteria: * Children had grade 4 anaphylaxis due to cow's milk ingestion. * Children are younger than 12 months old at the moment of passing 20' cooked cow's milk OFC. * Parents are not able or not willing to adhere to a specific cow's milk protein-containing diet on a regular basis at home. * Multiple food allergy, not compatible with any of the choices in the Flemish Milk Ladder. * Parents and/or children are not willing to give IC/assent.
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What it tests

  • Implementation of cow's milk in decreasingly heated forms
  • Implementation of heated cow's milk
  • No intervention
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Where

5 sites
Imelda Hospital Bonheiden
Bonheiden, Belgium
AZ Sint-Jan
Bruges, Belgium
AZ Maria Middelares
Ghent, Belgium
Jessa Hospital
Hasselt, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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