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NCT Number: NCT07448740

Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda Hospital, Bonheiden, Belgium

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About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test

    Time frame: 48 months

    The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.

Secondary outcomes

  1. Adverse clinical reactions to cow's milk protein intake during observational period

    Time frame: 48 months

    Nature and condition of clinical reactions in relation to different heated and/or unheated forms of cow's milk protein intake during observational period

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique MA Bullens, Prof, MD

CONTACT

[email protected]

+32016343801

Marleen Jannis

CONTACT

[email protected]

+32016343801

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Jan AV
  • Algemeen Ziekenhuis Maria Middelares
  • Imelda Hospital, Bonheiden
  • Jessa Hospital

Registry information

Acronym: Post-TEHITI

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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