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A spoonful of nuts? trial tests Multi-Allergy desensitization in kids

NCT ID NCT07764159

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether giving children with allergies to multiple nuts a daily oral immunotherapy—a mix of peanut, cashew, walnut, hazelnut, and almond proteins—can help them tolerate these foods. Children aged 1-12 with confirmed allergies to at least two of these nuts are randomly assigned to receive the immunotherapy or standard care (strict avoidance). The goal is to see if the treatment allows children to safely eat a meaningful amount of the allergens without a reaction, compared to those who just avoid the foods.

What this could mean

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

Active substance
Multi-food oral immunotherapy with a standardized mixture of peanut and tree nut proteins (cashew, walnut, hazelnut, almond)
What this could lead to
If successful, this approach could offer a practical way to desensitize children with multiple nut allergies, reducing the risk of severe reactions from accidental exposure.
What could go wrong
The trial is small and early, and oral immunotherapy carries risks of allergic reactions, including severe ones. It may not work for all children or all 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 39 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

Dec 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

1 year to 12 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 1-12 years; * Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and/or tree nuts: cashew, walnut, hazelnut, and almond; * Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and/or specific IgE (sIgE) level \> 0.35 kUA/L for at least two of the analyzed allergens; * Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein; * Participants may be enrolled based on the abbreviated procedure as outlined in the study description; * Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity; * Good prognosis for compliance and cooperation of the patient and their caregivers. Exclusion Criteria: * Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens; * History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history; * Severe asthma; * Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 \< -1.64 Z-score and/or FEV1/FVC \< -1.64 Z-score; * Eosinophilic gastrointestinal disease; * Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes; * Previous immunotherapy with food allergens; * Concurrent immunotherapy with aeroallergens; * Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers; * Oral corticosteroid therapy meeting any of the following criteria: daily treatment for \>1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months; * Lack of consent to participate in the study or insufficient cooperation of the patient and/or caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication. Well-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 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

  • Allergy Unit, Department of Pulmonary Diseases, Children's Hospital in Dziekanów Leśny

    Dziekanów Leśny, Masovian Voivodeship, 05-092, Poland

  • Department of Paediatric Pulmonology and Allergology, Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-091, Poland

  • Department of Pediatric Pulmonology, Allergology and Clinical Immunology, Institute of Pediatrics, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences

    Poznan, Greater Poland Voivodeship, 60-572, Poland

  • Department of Pediatrics, Children's Diseases Clinic, Jagiellonian University Medical Colleg, Division of Pulmonology, Allergology and Dermatology, University Children's Hospital in Kraków

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

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