Stepwise introduction of heat-treated cow's milk to build tolerance after previous treatment didn't work

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.