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Goat milk ladder may offer a new route to milk tolerance in allergic children

NCT ID NCT07795957

Disease control Sponsor: Medical University of Warsaw Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a four-step ladder made with goat milk formula helps children aged 1 to 5 with cow's milk allergy build tolerance to milk better than the standard cow's milk ladder. Both ladders start with baked goods and progress to plain milk over 12 weeks, with each step checked in a hospital. The main question is whether more children on the goat milk ladder can safely drink unheated cow's milk by the end. The study also tracks allergic reactions, quality of life, and caregiver anxiety.

What this could mean

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

Active substance
A four-step goat milk formula-based ladder (muffin, pancake, baked hard cheese, then pasteurized cow's milk) compared with a standard four-step cow's milk ladder
What this could lead to
If it works, children with cow's milk allergy might have a gentler, more effective way to build tolerance to milk, potentially shortening their elimination diet.
What could go wrong
This is an exploratory trial with a small number of participants, so results may not apply to all children. Allergic reactions, including anaphylaxis, are possible during the food challenges.

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 92 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 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.

Ages

1 year to 5 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: * Age between 1 and 5 years. * Diagnosis of IgE-mediated CMA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis occurring more than 6 months before enrolment) diagnosis may be established without a new OFC, based on a positive SPT wheal at least 3 mm greater than negative saline control and elevated specific IgE to CMPs \>0.35 kUa/L. * On a cow's milk-free, therapeutic elimination diet for at least 6 months, or since before 12 months of age. * Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma. * Overall good health status. * Parents/legal guardians able to understand the study procedures and communicate effectively with the study team. * Written informed consent provided by parents/legal guardians. * Expected good cooperation of the child's parents/legal guardians with the study team. Exclusion Criteria: * Uncontrolled asthma, defined as poor control according to the current GINA criteria, recent exacerbation requiring systemic corticosteroids or the need for medium to high-dose inhaled corticosteroids to maintain control * Signs of acute infectious disease (i.e., acute runny nose, cough, or fever). * Clinically relevant, uncontrolled exacerbation of another allergic disease that, in the investigator's judgement, could compromise OFC interpretation or safety (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis). * History of anaphylaxis due to cow's milk proteins within the last 6 months. * Use of antihistamines within 3-10 days before the OFC, depending on the drug's pharmacokinetics and indication (time-limited contradiction - relative exclusion criterion). * Documented tolerance to baked CMPs or to higher steps of the milk ladder. * Use of immunosuppressive drugs or ongoing allergen immunotherapy.

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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's milk allergy Cow's milk protein 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

    2 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

  • Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, Łódź, Poland

    Lodz, Poland

  • Medical Univeristy of Warsaw, Department of Paediatrics

    Warsaw, Poland

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