Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial

Hypothesis:

Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

Previous studies have shown that fecal calprotectin (FC) may be useful to predict relapse of inflammatory bowel disease and response to treatment. Current methods for measurement of FC require bringing stool samples to the laboratory or physician's office. The test is either not readily available or is expensive for patients. Some patients also find it inconvenient to collect, transport and travel to return the sample.

A prior study in our institution showed that only 77% of patients returned samples for processing. Therefore, a home-based kit may offer greater uptake by patients as samples do not need to be returned to a lab or physician's office. Regular monitoring of patients at home may allow the detection and prediction of flares before the appearance of symptoms. With earlier treatment, the risk of complications may be minimized and the quality of life for people living with this disease may be improved.

Inclusion Criteria:

• Patients age 19 years or older with Ulcerative Colitis
• Symptomatic remission defined as a modified Partial Mayo score ≤ 2 with a rectal bleeding score = 0
• Able to use IBDocTM test kit which requires a smart phone with a camera and internet access to download the CalApp® which interprets the measurement
• Able to give informed consent to the study protocol

Exclusion Criteria:

• Patients experiencing a symptomatic flare
• Patients currently receiving therapy as part of a clinical trial
• Pregnancy