PRO-ACTIVE FECAL CALPROTECTIN MONITORING TO IMPROVE PATIENT OUTCOMES IN ULCERATIVE COLITIS: A PROSPECTIVE RANDOMISED CONTROL TRIAL (PROMOTE UC)
PI: Dr. Greg Rosenfeld, University of British Columbia
Dr Yvette Leung, University of British Columbia
Dr Brian Bressler, University of British Columbia
Dr Alice Moore
The purpose of this study is to assess the use of a home-based Fecal Calprotectin measurement as a way to monitor mucosal inflammation in patients with UC and make changes to therapy prior to the onset of clinical symptoms, thereby preventing, delaying or minimizing clinical relapses. All subjects with mild to moderate UC in symptomatic remission are included.
PROMOTE-UC is an observational study monitoring fecal calprotectin (FC) in patients with Ulcerative colitis. Subjects are randomized and studied in two groups: the control group and the intervention group: The control group will receive current standard of care as the usual practice of the attending physician. Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on the baseline visit and month 6, 12 and month 18. The Intervention group will regularly monitor fecal calprotectin (FC) with IBDocTM, whereas the Control group will complete one IBDocTM at baseline followed by another at the end of the study. Fecal Calprotectin (FC) measurements with IBDocTM home kits will be performed by participants in the intervention group every 2 months until final visit. Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on baseline visit and month 6, 12 and month 18.
University of British Columbia; St. Paul’s Hospital/Providence Health Care
Mount Sinai Hospital, Toronto, ON
London Health Sciences Centre, ON
Kingston General Hospital
Winnipeg Regional Health Authority – Health Sciences Centre
Hamilton Health Sciences Centre, ON
McGill University Health Centre, QC
Nova Scotia Health Authority, Halifax, NS
[Private Clinic], Kelowna, BC
[Private Clinic], New Westminster, BC
Victoria, British Colombia
Sydney (Liverpool Hospital), Australia
Ottawa Hospital Research Institute, ON
University of Calgary, AB
Thunder Bay Regional Health Sciences Centre, ON
For more information on Inclusion & Exclusion Criteria, click here.
Anticipated sample size: 654
Reimbursement provided on a per patient basis. Additional sites are needed and any CIRC member sites interested in participating are invited to contact Greg Rosenfeld at firstname.lastname@example.org.