Clinical trial NCT03549988: Pro-active Fecal Calprotectin Monitoring PROMOTE-UC
Official title: Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Fecal calprotectin
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 726
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of 756 patients with Ulcerative colitis in symptomatic remission. Through the Canadian Intestinal Research Consortium (CIRC), we intent to involve a minimum of 12 sites across Canada, Europe and Australia.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The time to a symptomatic flare, defined as an increase in modified partial Mayo score > 2 points from baseline or a rectal bleeding score > 1
timeFrame: 6 months
Secondary outcomes:
measure: Hospitalization, surgery, steroid or biologic use
timeFrame: 6 months
measure: Proportion of subjects who underwent an escalation of therapy
timeFrame: 6 months
measure: Quality of life measured by SIBDQ questionnaire
timeFrame: 6 months
measure: Quality of life measured by EQ-5D 5L questionnaire
timeFrame: 6 months
measure: Number of physician visits
timeFrame: 6 months
measure: Time lost from work or school
timeFrame: 6 months
measure: Correlation of fecal calprotectin with endoscopic activity
timeFrame: 6 months
measure: Correlation of fecal calprotectin with histologic disease activity
timeFrame: 6 months
measure: Successful use of IBDoc
timeFrame: 2 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates
state: British Columbia
Study officials:
affiliation: University of British Columbia, Depart. of Medicine, Div. of Gastroenterology
name: Gregory Rosenfeld, MD
role: PRINCIPAL_INVESTIGATOR
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