NCT07448740 Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
| NCT ID | NCT07448740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Cow's Milk Protein Allergy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2030-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-03-31 with a primary completion date of 2030-10-24.
⚠ 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
Subjects who failed to become tolerant within 12 months after randomization within one of the three arms in the TEHITI study, can participate in the post-TEHITI observational trial to study the natural tolerance induction process.
Eligibility Criteria
Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * participation in s68299 * failure to challenge test with unheated cow's milk * passed challenge test with unheated cow's milk but with symptoms developing between challenge and termination visit related to cow's milk intake at home Exclusion Criteria: Participants eligible for this study must not meet any of the following criteria: * Subjects not priorly enrolled in s68299 * Subjects enrolled in s68299 who passed the challenge test and have no complaints upon regular cow's milk consumption at termination visit * Subjects who refuse to consent/assent with the study
Contact & Investigator
Jasmine Leus, MD
PRINCIPAL INVESTIGATOR
Maria Middelares Hospital, Gent
Frequently Asked Questions
Who can join the NCT07448740 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Cow's Milk Protein Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07448740 currently recruiting?
Yes, NCT07448740 is actively recruiting participants. Contact the research team at dominique.bullens@uzleuven.be for enrollment information.
Where is the NCT07448740 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 NCT07448740 clinical trial?
NCT07448740 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jasmine Leus, MD at Maria Middelares Hospital, Gent. The trial plans to enroll 30 participants.