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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07448740

Acronym

Post-TEHITI

Enrollment

Registered

2026-03-04

Start date

2025-03-31

Completion date

2030-10-24

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Protein Allergy

Brief 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.

Detailed description

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test	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

Measure	Time frame	Description
Adverse clinical reactions to cow's milk protein intake during observational period	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

Countries

Belgium

Contacts

CONTACTDominique MA Bullens, Prof, MD

dominique.bullens@uzleuven.be+32016343801

CONTACTMarleen Jannis

marleen.jannis@uzleuven.be+32016343801

PRINCIPAL_INVESTIGATORJasmine Leus, MD

Maria Middelares Hospital, Gent

PRINCIPAL_INVESTIGATORKatrien Coppens, MD

Imelda Hospital, Bonheiden

PRINCIPAL_INVESTIGATORSophie Verelst, MD

Jessa Hospital, Hasselt and KU Leuven

PRINCIPAL_INVESTIGATORKate Sauer, MD

AZ Sint-Jan AV

Outcome results