Boiled cashew treatment for children with food allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of boiled cashew oral immunotherapy in children aged 3-17 with confirmed cashew allergies. Participants will be randomly assigned to receive either boiled cashew or a placebo for 52 weeks, with regular monitoring for safety and compliance. The study aims to assess immunological changes and the potential for cross-desensitization to other tree nuts, such as pistachio, through controlled food challenges at specified intervals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Agnes Leung, MBChB
• Email: agnes.syl@cuhk.edu.hk
• Phone: 35052859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.