NCT03549988

Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 726 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Fecal Calprotectin (FC) measurements with IBDocTM	Each IBDocTM kit measure one fecal calprotectin value. The IBDoc® is an in-vitro diagnostic immunoassay analyzed by a downloadable smartphone application (CalApp®). A patient is able to process their stool at home using a test cassette. The IBDocTM test results are displayed in a light signal system as three titre categories; normal \<100 µg/g (green), 100-300 µg/g (yellow), \>300 µg/g (high). Patients' results will be sent directly to the central research coordinator through the IBDoc® Web Portal. If the FC is \>250 µg/g a second FC will be performed within 2 weeks. If this result is \<250 µg/g patients will continue to monitor their FC every 2 months. If the second result is \>250 µg/g, the attending physician will review the patient either by telephone or in the office within 7 days.

Timeline

• Start date: 2018-12-01
• Primary completion: 2025-12-30
• Completion: 2026-12-31
• First posted: 2018-06-08
• Last updated: 2025-04-09

Locations

1 site across 1 country: Canada