Boiled cashew treatment for children with food allergies
A Randomised, Controlled Trial Evaluating the Effectiveness of Boiled Cashew OraL immunoTherapy (BOLT) in Inducing Desensitisation or Remission in Children With Cashew Nut Allergy Compared With Placebo
This study is testing if giving boiled cashews to children with cashew allergies can help them safely eat cashews and possibly other tree nuts too.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06467994 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-17 with a confirmed diagnosis of cashew nut allergy.
Not a fit: Patients with a history of severe anaphylaxis or those who have experienced severe reactions during initial testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing cashew allergies in children.
How similar studies have performed: Preliminary studies on oral immunotherapy for food allergies have shown promise, but this specific approach using boiled cashews is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 3 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 this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.