Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06467994
Study type	Interventional
Source	Chinese University of Hong Kong
Contact	Agnes Leung, MBChB
Phone	35052859
Email	agnes.syl@cuhk.edu.hk
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2024
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT03089476` - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy	N/A
Recruiting	`NCT05839405` - Food Allergy in the Brain
Completed	`NCT02552537` - iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions	Phase 4
Completed	`NCT01634737` - Crustacean Allergy and Dust Mites Sensitization	N/A
Recruiting	`NCT05521711` - TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation	N/A
Completed	`NCT05072665` - Fast Allergy Sensitivity Test	N/A
Active, not recruiting	`NCT04887441` - Allergology: Information, Data and Knowledge Organization
Recruiting	`NCT03265262` - The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy	N/A
Completed	`NCT04186949` - Early Origins of Allergy and Asthma
Completed	`NCT02490007` - Pertussis Immunisation and Food Allergy
Recruiting	`NCT03151252` - Improvement of Foodallergy Diagnostic in Gastrointestinal Tract	N/A
Completed	`NCT02159833` - Intranasal Diagnostics in Food Allergy: a Feasibility Study	N/A
Completed	`NCT02354729` - Encouraging Allergic Young Adults to Carry Epinephrine	N/A
Completed	`NCT02377284` - Prevention and Management of Food Allergies	N/A
Completed	`NCT02640560` - One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish	N/A
Enrolling by invitation	`NCT06097572` - Improved Diagnostics in Food Allergy Study	N/A
Recruiting	`NCT04606615` - Skin Barrier Abnormalities and Oxidative Stress Response
Recruiting	`NCT05785299` - Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy	N/A
Not yet recruiting	`NCT06112873` - Quality of Life in Food Allergy: Validation of Three Mini-questionnaires
Completed	`NCT03337802` - Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.