Actively Recruiting
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Led by Hamilton Health Sciences Corporation · Updated on 2024-06-03
60
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
A
AAAAI Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.
CONDITIONS
Official Title
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Allergic to tree nut with baseline threshold of 444 mg protein or less
- Provides consent, and where applicable, assent
- Age between 1 and 16 years
You will not qualify if you...
- History of anaphylaxis to tree nut causing shock, syncope, or intubation
- Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
- Severe (GINA severity class 5) or uncontrolled asthma, including exacerbation within past 6 months
- Use of biologics, other food immunotherapy, or experimental treatment in past 6 months
- Ongoing severe allergic diseases preventing discontinuation of antihistamines for 7 days prior to assessment visits
- Pregnancy or significant medical conditions such as liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease
- Allergy to the oat-based placebo
- Any condition judged by local investigator to put participant at excessive risk for food allergic reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McMaster University Medical Centre
Hamilton, Ontario, Canada
Actively Recruiting
Research Team
H
Heather Le
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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