NCT06380673 Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy
| NCT ID | NCT06380673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-04-22 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Jasmine Leus, MD
PRINCIPAL INVESTIGATOR
Maria Middelares Hospital, Gent
Frequently Asked Questions
Who can join the NCT06380673 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380673 currently recruiting?
Yes, NCT06380673 is actively recruiting participants. Contact the research team at dominique.bullens@kuleuven.be for enrollment information.
Where is the NCT06380673 trial being conducted?
This trial is being conducted at Bonheiden, Belgium, Bruges, Belgium, Ghent, Belgium, Hasselt, Belgium and 1 additional location.
Who is sponsoring the NCT06380673 clinical trial?
NCT06380673 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jasmine Leus, MD at Maria Middelares Hospital, Gent. The trial plans to enroll 90 participants.