RecruitingNot ApplicableNCT05521711
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Sponsor
Hamilton Health Sciences Corporation
Enrollment
60 participants
Start Date
Sep 1, 2023
Study Type
INTERVENTIONAL
Summary
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.
Eligibility
Min Age: 1 YearMax Age: 16 Years
Inclusion Criteria1
- Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Exclusion Criteria6
- History of anaphylaxis to tree nut severe enough to cause 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 other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
- Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator
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Interventions
OTHERFood
Commercially available powders or liquids
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05521711