Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467994
• Other study ID #: BOLT01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Chinese University of Hong Kong
• Contact: Agnes Leung, MBChB
• Phone: 35052859
• Email: agnes.syl[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a two-arm, parallel-design, double-blind, randomized controlled trial. Participants aged 3-17 years of age with double blind placebo-controlled food challenge-confirmed cashew allergy will be randomised into either the active or placebo arm. The active and placebo participants will consume daily dose of cashew and placebo, respectively, for 52 weeks. Participants will undergo an initial escalation and build-up phase until they reach a maintenance dose of cashew or placebo. Participants will return at 6 months for a safety and compliance check and at 12 months (T1) and 14 months (T2) for endpoint oral food challenges. Level of cross-desensitization to pistachio will be examined at T1. Immunological changes, including sIgE and IgG4, will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Allergy
• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Cashew oral immunotherapy
Cashew Flour (boiled/ roasted) that is prepared under food manufacturing regulations
• Placebo oral immunotherapy
Placebo oral immunotherapy consists of corn flour with food colouring that has similar appearance, taste and smell to the active product

Locations

Country	Name	City	State
Hong Kong	Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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