Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

University of British Columbia

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Treatments: Other: Fecal Calprotectin (FC) measurements with IBDocTM

Study type: Observational

Funder types: Other

Identifiers

NCT03549988

H18-00647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 726 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

726 participants in 2 patient groups

Control

Description:

The 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. When endoscopy is performed biopsies should be taken and the endoscopic and histologic assessment will be recorded. If a fecal calprotectin is measured, every effort should be made to use the IBDoc with the result being sent to the central primary investigator via the IBDoc Web Portal. However, should a different fecal calprotectin measure be used, this will be recorded as part of the study documentation and will be included in the study data.

Intervention: FC measurements with IBDoc

Description:

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.

Treatment:

Other: Fecal Calprotectin (FC) measurements with IBDocTM