An observational study in Cow's Milk Protein Allergy, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 5 sites in Belgium. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
In this observational study the investigators will study the time to complete tolerance in cow's milk allergic children who tolerate 20' heated milk but failed the OFC with unheated milk 12 months after passing the 20' boiled cow's milk OFC. Moreoever, the investigators want to document all clinical reactions and potential cofactors during the tolerance induction process. The investigators anticipate that the whole cohort will become tolerant in a time span shorter than 48 months. Therefore the study period in each participant will be 48 months or the period to achieve complete tolerance (which comes first).
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 30 is below the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children participating in study s68299 who fail the challenge test with unheated cow's milk 12 months after initiation of the TEHITI trial, can be enrolled in this post-TEHITI study. Upon IC (and assent if appropriate) parents (and children) can participate in the current post-TEHITI observational trial. Upon enrollment in the post-TEHITI trial, specific data will be pseudonymised and collected during the clinical follow-up visits:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants eligible for inclusion in this study must meet all of the following criteria:
Exclusion Criteria:
Participants eligible for this study must not meet any of the following criteria:
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test
The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.
Time frame: 48 months
Adverse clinical reactions to cow's milk protein intake during observational period
Nature and condition of clinical reactions in relation to different heated and/or unheated forms of cow's milk protein intake during observational period
Time frame: 48 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2030, 66 months after the start.
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