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Boiled cashews could be key to taming cashew allergies in kids

NCT ID NCT06467994

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether eating small, increasing amounts of boiled cashew flour can help children with cashew allergy tolerate the nut without severe reactions. 75 children aged 2 to 17 will receive either boiled cashew flour or a placebo over time. The goal is to see if this approach can safely desensitize them or even lead to short-term remission.

What this could mean

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

Active substance
boiled cashew flour (oral immunotherapy)
What this could lead to
If it works, this could offer a safer way to help children with cashew allergy tolerate cashews without severe reactions, reducing daily anxiety and emergency risks.
What could go wrong
This is an early Phase 2 trial with only 75 children. The treatment may not work for everyone, and allergic reactions during therapy are possible. Long-term remission is uncertain.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Started

Jun 2024

Expected to finish

Jun 2028

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

2 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: * Aged between 2 year and 17 years of age; * Either sex, and of any race and ethnicity; * \>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext); * Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashew nut and a positive SPT (\>=3mm than control) or sIgE to cashew nut (of at least 0.35 kUA) at screening. * Subject's parent and/ or guardian must be able to understand and provide informed consent. Exclusion Criteria: * History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) * Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) * Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders) * Reacting to the placebo component during the study entry DBPCFC * FEV1 \<85% at rest and FEV1/FVC ≤ 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines) * Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis * Use of beta-blockers, ACE inhibitors or calcium channel blockers * Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis * Have received other food immunotherapy treatment in the preceding 6 months * Currently taking immunomodulatory therapy (including allergen immunotherapy) * Therapy with anti-IgE or other biologics within 1 year of enrolment * Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant * History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE) * Subjects who in the opinion of the Site Investigator are unable to follow the protocol NOTE: participants with other food allergies are NOT excluded from participating in this trial.

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Conditions

The condition(s) this trial relates to.

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

    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, Prince of Wales Hospital, The Chinese University of Hong Kong

    RECRUITING

    Hong Kong, Hong Kong

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