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Could a daily powder cure food allergies in kids?

NCT ID NCT06533462

Cure Sponsor: Karolinska Institutet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving young children (ages 0.5-3 years) a daily powder containing small amounts of 10 common allergens (like egg, milk, and peanut) can cure their food allergies. About 80 children with confirmed allergies will receive either the allergen powder or a placebo for 2 years. The goal is to see if they can then tolerate a larger dose of these foods without an allergic reaction.

What this could mean

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

Active substance
multi-allergen powder (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)
What this could lead to
If it works, this could offer a cure for multiple food allergies in young children, allowing them to eat these foods safely without ongoing treatment.
What could go wrong
This is an early-phase trial with only 80 children, so results may not apply to everyone. There is a risk of allergic reactions during treatment, and the approach may not work for all children.

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 80 people

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

Started

Nov 2024

Expected to finish

Dec 2027

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 months to 3 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: * 0.5-3 years old at inclusion with IgE (\>0.1 kUA/l) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew). * Written consent for participation in the study for both guardians. * 80 children (group A and B) also need a positive baseline food challenge. * Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge. Exclusion Criteria: * other serious illness * previous life-threatening anaphylaxis (intensive care) * eosinophilic esophagitis * eosinophilic gastrointestinal disease * severe chronic gastroesophageal reflux disease * unclear recurrent GI complaints * low body weight \<2SD * participation in another intervention study if included in intervention group * severe uncontrolled asthma * medication with biological drugs or oral steroids.

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Conditions

The condition(s) this trial relates to.

food allergy

As listed by the trial registrant

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

Food allergy Oral immunotherapy for 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

    1 site. 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

  • Södersjukhuset

    RECRUITING

    Stockholm, 11883, Sweden

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