Physicians of the Zane Cohen Centre
Clinical Trial for a dietary approach in Crohn's Disease
Details of Research
Contact:
Shlomit Boguslavsky, Clinical Research Coordinator
416-586-4800 x 8351
Shlomit.Boguslavsky@SinaiHealth.ca
Primary Investigator: Dr. Hillary Steinhart
Enrolment: Ongoing
Mount Sinai Hospital is participating in a research study to explore the effectiveness of the “Tasty&Healthy” dietary approach based on avoiding “pro-inflammatory” and processed ingredients, for inducing and maintaining remission in young adults.
We are looking for individuals:
- With Crohn’s Disease.
- Young adults aged 18-40
- Less than 3 years of disease duration
- In clinical remission or experiencing mild or moderate disease activity that warrants change in treatment
This study will last up to 24 weeks. Your Crohn’s Disease will be assessed and, if eligible, participants will be randomized into two randomized controlled trials both including the Tasty&Healthy dietary intervention for 8 weeks vs. 1) EEN (Modulen) in mild-moderate CD and vs. 2) a control group continuing their habitual diet. Responders from both trials will be offered to participate in an open label extension personalized-diet study of further 16 weeks (total 24 weeks). Reimbursement will be provided for study-related travel expenses and to assist in purchasing Tasty&Healthy foods.
Etrolizumab in CD
Details of Research
Contact: Shelley Mikolainis, Research Coordinator
416-586-4800 ext 4989
Shelley.Mikolainis@SinaiHealth.ca
Primary Investigator: Dr. Hillary Steinhart
Enrolment: Ongoing
Expectation: Cohort 1 will receive placebo, etrolizumab 105 mg SC Q4W (low dose), or etrolizumab 210 mg SC (high dose) 1:2:2 x 14-weeks, Cohort 2 will receive low-dose or high-dose regimens of etrolizumab. Cohort 3 will be randomized in a 2:3:3 ratio to receive placebo or etrolizumab low-dose or high-dose. Patients may be eligible for open-label treatment at week 14 of for entry into the Maintenance phase
Eligibility
- intolerance, refractory disease or no response to at least one of: Corticosteroids, immunomodulators or anti-TNF therapy within past 5 years
- Anti-TNF washout is 8 weeks prior to baseline
- infection treated with IV or oral antibiotics within last 4 weeks
Exclusion: draining fistula
Clinical Trial for oral medication in Crohn's Disease
Details of Research
Contact:
Shlomit Boguslavsky, Clinical Research Coordinator
416-586-4800 x 8351
Shlomit.Boguslavsky@SinaiHealth.ca
Primary Investigator: Dr. Hillary Steinhart
Enrolment: Ongoing
Mount Sinai Hospital is participating in a research study to understand the safety and effectiveness of an investigational medication for treating Crohn’s Disease.
This mediation is given orally (by mouth).
We are looking for individuals:
- With Crohn’s Disease.
- Experiencing symptoms related to their Crohn’s Disease.
- Have previously and/or currently not responded to one of the following standard treatments:
- Corticosteroids (e.g. Prednisone, Budesonide)
- Immunosuppressants (e.g., Imuran, Methotrexate, 6-MP)
- Biologic Therapy (e.g., Remicade, Humira, Stelara)
This study will last up to 4.5 years. Your Crohn’s Disease will be assessed and, if eligible, participants will be randomized in a 2:1 ratio to receive study medication or placebo ("dummy" drug). If your Crohn’s Disease has not improved by week 12 of the study, you may be eligible for the open-label (no placebo) portion of the study. Reimbursement will be provided for study-related travel expenses.