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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

As the global prevalence of food allergy steadily increases, tree nut (TN) becomes one of the main triggers of food-allergic reactions and food anaphylaxis. Since there is no effective cure, TN-allergic patients and their families must continue to live with this chronic, disabling condition while avoiding allergens and responding to allergic reactions with emergency treatment. An emerging experimental treatment for food allergy is oral immunotherapy (OIT). Tree nut OIT appears promising in preliminary studies but there are concerns about the high risk of adverse reactions to TNs used in the treatment. The rate of remission with TN OIT is also lacking. Identification of OIT regimes with increased efficacy and safety is urgently needed. The investigators revealed that boiled cashews had lower allergenic potential but retained mast cell reactivity. The aim of this proposed study is to investigate the efficacy and safety of a novel treatment strategy for TN-allergic individuals, whereby the investigators hypothesized that consuming increasing quantities of boiled cashews can induce desensitization/ remission to roasted tree nuts in children with cashew allergies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Agnes Leung, MBChB
agnes.syl@cuhk.edu.hk
35052859
Backup
Ann Au, APD (DA)
annwsau@cuhk.edu.hk
35052829
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 75
Treatments
Active_comparator: Cashew Oral Immunotherapy
Oral immunotherapy with boiled cashews followed by roasted cashews taken daily for 12 months
Placebo_comparator: Placebo Oral Immunotherapy
Placebo oral immunotherapy taken daily for 12 months
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov