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

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).

Conditions

• Food Allergy
• Cow Milk Allergy

Interventions

OTHER

Implementation 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.

OTHER

Implementation 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.

OTHER

No intervention

Healthy subjects undergo no intervention.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Jasmine Leus, MD · Maria Middelares Hospital, Gent

• Katrien Coppens, MD · Imelda Hospital, Bonheiden

• Sophie Verelst, MD · KU Leuven and Jessa Hospital, Hasselt

• Kate Sauer, MD · AZ Sint-Jan AV

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-22

Primary Completion

2028-12-30

Completion

2029-12-30

Countries

• Belgium

Study Locations