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Can kids outgrow milk allergy on their own? new study watches and waits

NCT ID NCT07448740

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 30 children with cow's milk allergy who did not become tolerant after a previous treatment. Researchers will observe whether these children naturally develop tolerance over time without any new intervention. The goal is to better understand the natural course of the allergy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand how some children naturally outgrow cow's milk allergy after initial treatment failure.
What could go wrong
This is a small observational study with only 30 participants, so results may not apply to everyone. It does not test a new treatment, only observes natural changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

1 year to 18 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cow's milk protein allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Maria Middelares

    RECRUITING

    Ghent, Belgium

  • AZ Sint Jan

    RECRUITING

    Bruges, Belgium

  • Imelda Hospital

    RECRUITING

    Bonheiden, Belgium

  • Jessa Hospital

    RECRUITING

    Hasselt, Belgium

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, Belgium

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