RecruitingNot ApplicableNCT06380673

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

90 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 1 YearMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

OTHERImplementation 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.

OTHERImplementation 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.

OTHERNo 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

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NCT06380673


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