Evaluating new ways to treat tree nut allergies
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
This study is testing new ways to treat tree nut allergies using different methods to see if they are safer and easier for people with these allergies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05521711 on ClinicalTrials.gov |
What this trial studies
The TRADE trial focuses on assessing the efficacy and safety of sublingual immunotherapy and lower doses of oral immunotherapy for individuals with tree nut allergies. This randomized controlled trial aims to determine if these alternative methods can provide a more tolerable treatment option compared to current standards. Participants will be monitored for their allergic reactions and overall response to the treatment. The study seeks to improve the management of tree nut allergies through innovative immunotherapy approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals allergic to tree nuts with a baseline threshold of 444 mg protein or less.
Not a fit: Patients with a history of severe anaphylaxis to tree nuts or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to safer and more effective treatment options for patients with tree nut allergies.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches for food allergies, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent. Exclusion Criteria: 1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation 2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years 3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months 4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months. 5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits 6. 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
Where this trial is running
Hamilton, Ontario
- McMaster University Medical Centre — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Derek Chu, MD PhD FRCPC — Hamilton Health Sciences & McMaster University
- Study coordinator: Heather Le
- Email: lehea@hhsc.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.