Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

N/AActive Not RecruitingNCT03549988

University of British Columbia726 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

726

Conditions

Ulcerative Colitis

Interventions

Fecal Calprotectin (FC) measurements with IBDocTMOTHER

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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

All patients in both control and intervention group will be contacted every 6 months until end of study. Partial Mayo and rectal bleeding score will be obtained and if there is an increase in partial Mayo score \> 2 points from baseline or a rectal bleeding score \> 1, this is considered as flare. Endoscopy will be performed wherever possible.

Time frame: 6 months

Secondary Outcomes

Hospitalization, surgery, steroid or biologic use

All patients in both control and intervention group will be asked every 6 months whether they were hospitalized, had undergone surgery, had used steroid (oral or rectal) or any biologics.

Time frame: 6 months

Proportion of subjects who underwent an escalation of therapy

Choice of therapy for all patients should be according to the standard of care and by the judgement of the attending physician.

Time frame: 6 months

Quality of life measured by SIBDQ questionnaire

Quality of life is measured by Short Quality of Life in Inflammatory Bowel Disease (SIBDQ) questionnaire. Both control and intervention group will be asked to complete these questionnaires on-line during baseline, month 6, 12 and month 18. The SIBDQ provide a measure of subjective health status or quality of life in patients with inflammatory bowel disease (IBD). It consists of four domains, bowel symptoms, emotional health, systemic systems and social function. The total score ranges from 10 (worst health) to 70 (best health).

Time frame: 6 months

Quality of life measured by EQ-5D 5L questionnaire

Quality of life is measured by EQ-5D 5L health questionnaire. Both control and intervention group will be asked to complete these questionnaires on-line during baseline, month 6, 12 and month 18. The EQ-5D-5L is a standardized measure of health status. It comprises of 5 dimensions like mobility, selfcare, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate his/her health state. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.

Data from ClinicalTrials.gov

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