Stepwise introduction of heat-treated cow's milk to build tolerance after previous treatment didn't work
Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
We will follow children with cow's milk allergy who can drink heated milk but still react to regular milk to see how long it takes them to become fully tolerant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 5 sites (Bonheiden and 4 other locations) |
| Trial ID | NCT07448740 on ClinicalTrials.gov |
What this trial studies
This observational cohort enrolls children previously in the TEHITI protocol who passed a 20-minute boiled milk oral food challenge but still failed the unheated milk challenge at 12 months. Participants will be followed for up to 48 months or until they achieve complete tolerance, with the exact time to tolerance recorded. Investigators will document all clinical reactions and potential cofactors during home reintroduction of cow's milk. No interventional treatment is mandated; routine care and careful monitoring are used to capture the natural tolerance induction process.
Who should consider this trial
Good fit: Children previously enrolled in the TEHITI (s68299) protocol who tolerate 20-minute heated milk but failed the unheated milk oral food challenge at the 12-month visit are eligible.
Not a fit: Children not previously enrolled in TEHITI, those who already tolerate unheated cow's milk without symptoms, or those who refuse consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the data could help families and clinicians predict when children who tolerate heated milk might safely reintroduce regular milk and reduce unnecessary dietary restriction.
How similar studies have performed: Prior reports indicate many children who tolerate heated milk later outgrow unheated milk allergy, but prospective data documenting timing and associated cofactors are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bonheiden and 4 other locations
- Imelda Hospital — Bonheiden, Belgium (Recruiting)
- AZ Sint Jan — Bruges, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
- Jessa Hospital — Hasselt, Belgium (Recruiting)
- UZ Leuven Gasthuisberg — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Jasmine Leus, MD — Maria Middelares Hospital, Gent
- Study coordinator: Dominique MA Bullens, Prof, MD
- Email: dominique.bullens@uzleuven.be
- Phone: +32016343801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.