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

What this Trial Is About

Researchers are investigating a new treatment approach for children aged 2 to 17 years with confirmed cashew nut allergy. This trial evaluates whether consuming increasing amounts of boiled cashews can help children become less sensitive or even develop remission to roasted tree nuts, including cashews and pistachios. This approach aims to address the increasing global prevalence of tree nut allergies, which currently have no cure and require strict avoidance of allergens and emergency treatments for reactions. This is a double-blind, randomized controlled trial with two groups: one receiving oral immunotherapy with boiled cashews followed by roasted cashews daily for 78 weeks, and the other receiving a placebo that looks and tastes similar. Participants start with a dose escalation and build-up phase until reaching a maintenance dose. They return for safety and compliance checks at 12 months, and undergo oral food challenges at 18 and 20 months to assess desensitization and remission. Immune responses, such as specific antibodies, will also be measured. During the study, children will be regularly monitored with food challenges to measure their ability to tolerate cashew protein and pistachio nuts. Researchers will track adverse events, skin prick test reactions, and immune markers like IgE and IgG4. The primary outcome is the proportion of children who tolerate a full cashew protein challenge at 18 months. Secondary outcomes include sustained unresponsiveness and safety data collected up to 20 months. The total participation time is approximately 78 weeks with follow-up visits and evaluations throughout.

Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children