Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 17 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06467994
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chinese University of Hong Kong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Hong Kong
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy in Children, Food Allergy
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Other: - Cashew oral immunotherapy

Cashew Flour (boiled/ roasted) that is prepared under food manufacturing regulations

Other: - Placebo oral immunotherapy

Placebo oral immunotherapy consists of corn flour with food colouring that has similar appearance, taste and smell to the active product

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hong Kong, Hong Kong

Status

Recruiting

Address

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, ,

Site Contact

Agnes Leung

[email protected]

+85235052859

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