At a glance
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Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial
In Brief
An observational study evaluating Fecal Calprotectin (FC) measurements with IBDocTM for Ulcerative Colitis. Completed, enrolled 726 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.