RecruitingNCT07448740
Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
30 participants
Start Date
Mar 31, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 1 YearMax Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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
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Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07448740