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Can feeding allergens to toddlers build lasting food allergy tolerance?

NCT ID NCT07825662

Cure Sponsor: Copenhagen Studies on Asthma in Childhood 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers test whether daily oral immunotherapy can safely treat food allergy in children aged 0 to 2 with peanut, tree nut, or sesame allergy. Half the children receive the therapy, starting with tiny amounts of the allergen and building up over about six months, then a year of daily maintenance. The other half avoid the allergen as usual. The trial also tracks immune, microbiome, and genetic markers to see who responds and whether tolerance lasts.

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 the allergenic food (peanut, tree nut, or sesame)
What this could lead to
If it works, this could point toward a way to build lasting tolerance to food allergens in very young children, possibly reducing the need for lifelong avoidance.
What could go wrong
This is an early trial in a small group of toddlers, and oral immunotherapy can trigger allergic reactions during dosing. Many children may not reach lasting tolerance, and the results may not apply to older children or other allergens.

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 120 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

Jun 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

Up to 24 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: * Children age 0-2 years * Diagnosed IgE-mediated food allergy to tree-nuts, sesame, and/or peanuts, defined as: Positive oral food challenge (OFC) at inclusion or within 6 months before AND positive SPT (≥ 3 mm) or specific IgE (≥ 0.35 kUA/L) * Both parents provide informed consent Exclusion Criteria: * Already undergoing any form of immunotherapy * Already undergoing any form of biological treatment * Medical conditions precluding OITs: Uncontrolled asthma, atopic dermatitis requiring systemic therapy, eosinophilic esophagitis (EoE) and other GI-diseases, other severe immunological diseases (e.g. inborn errors of immunity )

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Conditions

The condition(s) this trial relates to.

food allergy Nut Hypersensitivity Peanut Hypersensitivity

As listed by the trial registrant

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

Food allergy in children 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

  • Department of Paediatrics, Herlev Hospital

    Herlev, Capital Region, 2730, Denmark

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