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Can cashew allergy be outgrown? new study tests oral immunotherapy

NCT ID NCT07158619

Disease control Sponsor: Medical University of Warsaw 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 39 children with cashew allergy who previously received oral immunotherapy (OIT) with cashew protein. After 8 more months of OIT, they will stop treatment for 4 weeks and then take a food challenge to see if they can safely eat cashews without ongoing therapy. The goal is to find out if sustained unresponsiveness—lasting tolerance—can be achieved.

What this could mean

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

Active substance
cashew nut protein (oral immunotherapy)
What this could lead to
If successful, this could show that a period of oral immunotherapy helps children with cashew allergy eat cashews safely even after stopping treatment.
What could go wrong
This is a small, early follow-up study with only 39 participants. It is not yet recruiting, and results may not apply to all children. Allergic reactions during treatment are possible.

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 39 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

May 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

4 to 17 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: * Cashew nut allergy confirmed prior to the initiation of immunotherapy * Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy * Provision of informed consent for participation in the study * Adequate cooperation from the patient and/or their legal guardians Exclusion Criteria: * Severe asthma * Poorly controlled mild-to-moderate asthma, defined as: * FEV1 \< 80% (below the 5th percentile), * FEV1/FVC ratio \< 75% (below the 5th percentile), * Hospitalization due to asthma exacerbation within the past 12 months * Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy * Eosinophilic gastrointestinal disorders * Severe, recurrent episodes of anaphylaxis within the last 6 months * Chronic illnesses requiring ongoing treatment, including: * Cardiac conditions * Epilepsy * Metabolic disorders * Diabetes mellitus * Use of the following medications: * Daily oral corticosteroid therapy \>1 month within the past 12 months * At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months * One course of oral corticosteroids (minimum 7 days) within the past 3 months * Biologic therapies * Treatment with β-blockers, ACE inhibitors, or calcium channel blockers * Pregnancy * Lack of informed consent for participation * Lack of cooperation from the patient

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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 in children

How to take part

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  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

  • Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-091, Poland

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