Post-failure Stepwise Heat-Denaturated Protein Introducti... | NCT07448740

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2025Actual

Primary Completion Date

Oct 24, 2030Estimated

Completion Date

Oct 24, 2030Estimated

First Submitted Date

Nov 29, 2024

First Submission Date that Met QC Criteria

Feb 28, 2026

First Posted Date

Mar 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2026

Last Update Posted Date

Mar 4, 2026Actual

Name	Class
Jessa Hospital	OTHER
Imelda Hospital, Bonheiden	OTHER
Algemeen Ziekenhuis Maria Middelares	OTHER
AZ Sint-Jan AV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

48 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	48 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominique MA Bullens, Prof, MD	Contact	+32016343801		dominique.bullens@uzleuven.be
Marleen Jannis	Contact	+32016343801		marleen.jannis@uzleuven.be

Overall Officials

Name	Affiliation	Role
Jasmine Leus, MD	Maria Middelares Hospital, Gent	Principal Investigator
Katrien Coppens, MD	Imelda Hospital, Bonheiden	Principal Investigator
Sophie Verelst, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imelda Hospital	Recruiting	Bonheiden			Belgium

ID	Term
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases