Introducing heated cow's milk to help children with milk allergies develop tolerance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study focuses on children with cow's milk allergy who have developed tolerance to extensively heated cow's milk. The aim is to validate a protocol for gradually introducing less heated cow's milk proteins over 12 months to accelerate the development of complete tolerance. Participants will undergo oral food challenges and have their immunological responses monitored through blood tests. The study will assess the effectiveness of this approach in reducing the time to achieve full tolerance and improving the quality of life for both children and their families.

Why it matters

Who can join: the full rules

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.

Where it's running

• Imelda Hospital Bonheiden
  Bonheiden, Belgium Recruiting
• AZ Sint-Jan
  Bruges, Belgium Recruiting
• AZ Maria Middelares
  Ghent, Belgium Recruiting
• Jessa Hospital
  Hasselt, Belgium Recruiting
• UZ Leuven Gasthuisberg
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Jasmine Leus, MD — Maria Middelares Hospital, Gent
• Study coordinator: Dominique MA Bullens, Prof. MD
• Email: dominique.bullens@kuleuven.be
• Phone: +32016343801

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.