Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk… (NCT07448740) | Clinical Trial Compass
RecruitingNot Applicable
Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
Belgium30 participantsStarted 2025-03-31
Plain-language 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.
Who can participate
Age range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test