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A spoonful of milk a day: could it rewire Kids' allergies?

NCT ID NCT07768696

Disease control Sponsor: Laura Ozer Kettner Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether giving children with cow's milk allergy tiny, increasing amounts of milk each day can help them tolerate it. Infants aged 6 to 18 months with a confirmed allergy will be randomly assigned to receive oral immunotherapy for 1-1.5 years or to avoid milk as usual. After the treatment period, all children will undergo a food challenge to see how much milk they can handle. The study also tracks allergic reactions and allergy-related blood markers to understand how the approach works.

What this could mean

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

Active substance
Oral immunotherapy with cow's milk
What this could lead to
If successful, this could offer a way to help young children with cow's milk allergy safely build tolerance, reducing dietary restrictions and anxiety.
What could go wrong
This is a small, early-stage trial. The treatment involves daily milk intake and may cause allergic reactions. Results may not apply to all children with milk allergy.

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 56 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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

6 to 18 months

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: * Aged 6 to 18 months * Cow's milk allergy confirmed at an oral food challenge * Reaction threshold below 300 mg of cow's milk protein at the oral food challenge * Specific IgE to cow's milk \> 0.35 kU/L * High risk of persistent allergy to cow's milk (based on defined criteria) * Family motivated for oral immunotherapy following shared decision-making using a decision aid Exclusion Criteria: * Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis * Treatment with biologic or immunosuppressive medication * Non-Danish-speaking families * Anticipated non-adherent families

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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.

Food allergies Food allergy in children Milk allergy, cow's

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

  • Regional Hospital Gødstrup

    Gødstrup, Denmark

  • Regional Hospital Kolding

    Kolding, Denmark

  • Regional Hospital Randers

    Randers, Denmark

  • Regional Hospital Viborg

    Viborg, Denmark

  • The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital

    Aarhus, Denmark

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