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Heated milk ladder could speed up allergy tolerance in kids

NCT ID NCT06380673

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether gradually introducing cow's milk in less-heated forms over 12 months helps children with milk allergy develop full tolerance faster than just eating well-cooked milk. About 90 children aged 1-18 who already tolerate heated milk will be split into groups: one follows a stepwise plan (shorter cooking times or a milk ladder), another sticks with only well-cooked milk, and a third group of healthy kids serves as a control. The goal is to see if the stepwise approach leads to more children being able to drink regular milk safely after a year.

What this could mean

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

Active substance
heated cow's milk
What this could lead to
If it works, this could help children with cow's milk allergy develop full tolerance in about a year instead of several years, improving quality of life and reducing accidental reactions.
What could go wrong
This is an early-stage study with only 90 participants, so results may not apply to all children. There is a risk of allergic reactions during the stepwise introduction, and the approach may not work for everyone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Started

Apr 2024

Expected to finish

Dec 2029

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.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic. * Children are at least 12 months old before introduction of heated cow's milk is considered. * Children did not suffer from grade 4 anaphylaxis due to cow's milk-ingestion at presentation. * Children have specific IgE levels to Bos d 8 below 1.2 kU/mL and/or children passed 20' cooked cow's milk provocation test executed on clinical judgement. Exclusion Criteria: * Children had grade 4 anaphylaxis due to cow's milk ingestion. * Children are younger than 12 months old at the moment of passing 20' cooked cow's milk OFC. * Parents are not able or not willing to adhere to a specific cow's milk protein-containing diet on a regular basis at home. * Multiple food allergy, not compatible with any of the choices in the Flemish Milk Ladder. * Parents and/or children are not willing to give IC/assent.

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Conditions

The condition(s) this trial relates to.

food allergy Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

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

Cow milk allergy Food 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 Bonheiden

    RECRUITING

    Bonheiden, Belgium

  • Jessa Hospital

    RECRUITING

    Hasselt, Belgium

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, Belgium

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