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Study identifier: NCT06380673 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Food Allergy · Cow Milk Allergy  ·  Sponsor: Universitaire Ziekenhuizen KU Leuven

PhaseNA
Planned participants90
Who can joinAll sexes, 1 Year to 18 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Dominique MA Bullens, Prof. MD  ·  +32016343801  ·  dominique.bullens@kuleuven.be

Marleen Jannis  ·  +32016343801  ·  marleen.jannis@uzleuven.be

Always discuss trial participation with your own doctor first.

Locations (5)

Imelda Hospital BonheidenBonheiden, BelgiumRecruiting
AZ Sint-JanBruges, BelgiumRecruiting
AZ Maria MiddelaresGhent, BelgiumRecruiting
Jessa HospitalHasselt, BelgiumRecruiting
UZ Leuven GasthuisbergLeuven, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT06380673