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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 4 treatment groups