Actively Recruiting
Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
Led by Chinese University of Hong Kong · Updated on 2024-06-21
75
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 3 years and 17 years
- Any sex, race, and ethnicity
- Weighing more than 7 kg suitable for adrenaline autoinjector use
- Confirmed cashew nut allergy by failed double-blind placebo-controlled food challenge and positive skin prick test or specific IgE
- Parent or guardian able to provide informed consent
You will not qualify if you...
- History of severe anaphylaxis with persistent hypotension, collapse, loss of consciousness, or requiring more than 3 doses of adrenaline or intravenous adrenaline
- Severe anaphylaxis during study entry food challenge
- Conditions where adrenaline is contraindicated such as hypertension or heart rhythm disorders
- Reaction to placebo during study entry food challenge
- Lung function FEV1 <85% at rest or ongoing chronic persistent asthma
- Underlying medical conditions increasing anaphylaxis risk such as cardiac disease
- Use of beta-blockers, ACE inhibitors, or calcium channel blockers
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune compromise, recent major surgery, critical illness, or prolonged hospitalization
- Food immunotherapy treatment in past 6 months
- Current immunomodulatory therapy or allergen immunotherapy
- Anti-IgE or other biologic therapy within 1 year
- Major illness affecting ability to participate
- History or suspicion of eosinophilic oesophagitis
- Unable to follow study protocol as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Agnes Leung, MBChB
CONTACT
A
Ann Au, APD (DA)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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