Cow's Milk Protein AllergyPost-TEHITINCT07448740
Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
An observational study of Cow's Milk Protein Allergy, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cow's Milk Protein Allergy
- How many people
- 30 participants
- Where
- 5 sitesBelgium
- Study dates
- 31 Mar 2025to 24 Oct 2030
- How long will I take part?
- 48 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Imelda Hospital
Bonheiden
Katrien Coppens, MD
- Recruiting
AZ Sint Jan
Bruges
Kate Sauer, MD
- Recruiting
AZ Maria Middelares
Ghent
Jasmine Leus, MD
- Recruiting
Jessa Hospital
Hasselt
Sophie Verelst, MD
- Recruiting
UZ Leuven Gasthuisberg
Leuven
Dominique MA Bullens, Prof, MD
Marleen Jannis, +32016343801, marleen.jannis@uzleuven.be
About this 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.
Read the 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).
- Conditions
- Cow's Milk Protein Allergy
- Medical subject headings
- Milk Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (1)
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
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start31 Mar 2025
- Primary completion24 Oct 2030 (estimated)
- Study completion24 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Imelda Hospital, Bonheiden, Algemeen Ziekenhuis Maria Middelares, AZ Sint-Jan AV
- Responsible party
- Principal investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jasmine Leus, MD, Principal investigator, Maria Middelares Hospital, GentKatrien Coppens, MD, Principal investigator, Imelda Hospital, BonheidenSophie Verelst, MD, Principal investigator, Jessa Hospital, Hasselt and KU LeuvenKate Sauer, MD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448740
- Sponsor's protocol ID
- S68469
- Acronym
- Post-TEHITI
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07448740
- Acronym / sponsor ID
- Post-TEHITI / S68469
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Jessa Hospital, Imelda Hospital, Bonheiden, Algemeen Ziekenhuis Maria Middelares, AZ Sint-Jan AV
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 24 Oct 2030 (estimated)
- Study completion
- 24 Oct 2030 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Adverse clinical reactions to cow's milk protein intake during observational period
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmine Leus, MD principal investigator
Maria Middelares Hospital, Gent
Katrien Coppens, MD principal investigator
Imelda Hospital, Bonheiden
Sophie Verelst, MD principal investigator
Jessa Hospital, Hasselt and KU Leuven
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique MA Bullens, Prof, MD (+32016343801, dominique.bullens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.