Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
NCT Number: NCT06467994
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Food Allergy in Children|Food Allergy
Interventions: OTHER: Cashew oral immunotherapy|OTHER: Placebo oral immunotherapy
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: CHILD
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-12-31
Locations: Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong

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.

Primary Outcome Measures: Proportion of cashew-allergic subjects who by T1 DBPCFC tolerate the full challenge i.e. a cumulative dose of 3180 mg cashew protein, T1 - One day after final day of maintenance treatment
Secondary Outcome Measures: Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in OIT vs placebo groups, T2 - 8 weeks after final day of maintenance treatment|The cumulative dose tolerated during the T1 challenge (cumulative doses below the reaction-eliciting dose if there is a reaction; or total cumulative challenge dose if there is no reaction) in OIT vs placebo groups, T1 - One day after final day of maintenance treatment|Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in OIT vs placebo groups;, T1 - One day after final day of maintenance treatment|SPT wheal size to cashew (at the end of treatment, and at 8 weeks after end of treatment) in OIT vs placebo groups., T1 - One day after final day of maintenance treatment|Cashew-specific IgE levels (at the end of treatment, and at 8 weeks after end of treatment) in OIT vs placebo groups., T1 - One day after final day of maintenance treatment|Cashew-specific IgG4 levels (at the end of treatment, and at 8 weeks after end of treatment) in OIT vs placebo groups., T1 - One day after final day of maintenance treatment