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

NCT07448740 | Recruiting DMC

• 1 other identifier: S68469
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Cow's Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  48 months

Secondary Outcomes (1)

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

  48 months

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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: * Intake of cow's milk containing food products: amount, recipe, frequency of intake in the period between two follow-up consultations * Clinical reactions: description and recording of potential cofactors for their presentation * Medication use to treat the clinical reaction * Relation to cow's milk intake: certain/doubtful/absent * Specific IgE to cow's milk proteins in peripheral blood * Total IgE levels in peripheral blood Individual pseudonymisation will be done by similar code as given in TEHITI trial.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Jessa Hospital: collaborator
• Imelda Hospital, Bonheiden: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator
• AZ Sint-Jan AV: collaborator

Study Sites (5)

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

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jasmine Leus, MD

  Maria Middelares Hospital, Gent

  PRINCIPAL INVESTIGATOR

• Katrien Coppens, MD

  Imelda Hospital, Bonheiden

  PRINCIPAL INVESTIGATOR

• Sophie Verelst, MD

  Jessa Hospital, Hasselt and KU Leuven

  PRINCIPAL INVESTIGATOR

• Kate Sauer, MD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique MA Bullens, Prof, MD

CONTACT

+32016343801; dominique.bullens@uzleuven.be

Marleen Jannis

CONTACT

+32016343801; marleen.jannis@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dominique MA Bullens, MD PhD

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: March 4, 2026
• Study Start: March 31, 2025
• Primary Completion (Estimated): October 24, 2030
• Study Completion (Estimated): October 24, 2030
• Last Updated: March 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)