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Immunotherapy
Immunotherapy for Tree Nut Allergy (TRADE Trial)
N/A
Recruiting
Led By Derek Chu, MD PhD FRCPC
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
"This trial will test a new treatment method for tree nut allergies called immunotherapy to see if it is effective and safe. It will use lower doses of oral immunotherapy than what is typically used."
Who is the study for?
The TRADE Trial is for individuals who are allergic to tree nuts and react to 444 mg of nut protein or less. Participants must consent to the trial, and if they're minors, they need parental consent as well.
What is being tested?
This study tests two ways of treating tree nut allergies: sublingual immunotherapy (medicine placed under the tongue) and oral immunotherapy with lower doses than currently used. It's a randomized controlled trial, meaning participants are randomly assigned to different treatment groups.
What are the potential side effects?
Potential side effects may include itching in the mouth, stomach pain, nausea, or more severe allergy symptoms. The exact side effects will depend on how each person responds to the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Quality of life
Trial Design
3Treatment groups
Experimental Treatment
Group I: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapyExperimental Treatment1 Intervention
Group II: Placebo low dose oral immunotherapy and Active sublingual immunotherapyExperimental Treatment1 Intervention
Group III: Active low dose oral immunotherapy and Placebo sublingual immunotherapyExperimental Treatment1 Intervention
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Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
374 Previous Clinical Trials
339,976 Total Patients Enrolled
1 Trials studying Food Allergy
2,000 Patients Enrolled for Food Allergy
AAAAI FoundationUNKNOWN
1 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Food Allergy
2,000 Patients Enrolled for Food Allergy
Derek Chu, MD PhD FRCPCPrincipal InvestigatorHamilton Health Sciences & McMaster University
1 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Food Allergy
2,000 Patients Enrolled for Food Allergy
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