Boiled cashews could be key to taming cashew allergies in kids
NCT ID NCT06467994
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
RECRUITINGHong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A spoonful of milk a day: could it rewire Kids' allergies?