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

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

This study is testing if slowly introducing less heated cow's milk to children with milk allergies can help them develop a tolerance faster and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 5 sites (Bonheiden and 4 other locations)
• Trial ID: NCT06380673 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 1-18 years with a clinical diagnosis of IgE mediated cow's milk allergy who have passed a specific oral food challenge.

Not a fit: Patients who have experienced grade 4 anaphylaxis due to cow's milk ingestion or those with multiple food allergies incompatible with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the time it takes for children with cow's milk allergies to achieve complete tolerance, thereby improving their quality of life and reducing the risk of anaphylaxis.

How similar studies have performed: Previous studies have shown success with similar approaches for other food allergies, such as hen's egg allergy, indicating potential for this method in cow's milk allergy.

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.

Where this trial is running

Bonheiden and 4 other locations

• 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

Conditions Food Allergy; Cow Milk Allergy