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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help children with cow's milk allergy develop tolerance to cow's milk more quickly. The study involves introducing a specially prepared form of cow's milk that has been heated in a certain way. The goal is to see if this method can help more children safely consume cow's milk after 12 months compared to the usual approach, which requires strict avoidance of cow's milk for a long time. This could make life easier for both the children and their families by reducing the chances of severe allergic reactions.

To be eligible for this trial, children aged 1 to 18 must have a diagnosis of cow's milk allergy and show certain test results indicating they can handle a specific type of cooked cow's milk. Importantly, they should not have experienced severe allergic reactions (grade 4 anaphylaxis) from cow's milk. Participants can expect to follow a stepwise introduction of heated cow's milk over a year while being monitored for their reactions. Parents should also be committed to helping their child follow the diet required for the study. Overall, this trial aims to improve the safety and quality of life for children with cow's milk allergy.

Gender

ALL

Eligibility criteria

• 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.