Physicians of the Zane Cohen Centre

Contact: Ajani Jeyakumar, Clinical Research Coordinator

416-586-4800 ext 5953
Ajani.Jeyakumar@SinaiHealth.ca

Primary Investigator: Mark Silverberg, MD
Enrolment: Ongoing

Objective: The objective is to understand the safety and effectiveness of a new enema medication for treating pouchitis in patients who have previously and/or currently not responded to antibiotic treatment.

Expectation: This research will lead to improved treatment options for patients.

Mount Sinai Hospital is participating in a clinical trial that is looking at the safety and effectiveness of a new enema medication for treating pouchitis in patients who have previously and/or currently not responded to antibiotic treatment.

We are looking for individuals:

• With Ulcerative Colitis who have undergone an IPAA procedure
• Currently experiencing pouchitis (inflammation of the pouch lining)
• Have not responded to antibiotic treatmentis.

This study will last up to 29 weeks, during which you will see the study doctor and/or coordinator 8 times. Your pouchitis will be assessed and if eligible, participants will be randomized to take either active study medication or placebo ("dummy" drug) for 6 weeks. Daily diary entry will be required for up to 13 weeks. Reimbursement will be provided for travel expenses.

For more information please contact Ajani Jeyakumar (Study Coordinator) at 4165864800 ext 5953 or Dr. Mark Silverberg (Principal Investigator) at 4165864800 ext 8236