Pro-active Fecal Calprotectin Monitoring PROMOTE-UC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03549988|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : August 11, 2020
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.
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis||Other: Fecal Calprotectin (FC) measurements with IBDocTM|
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|
|Estimated Enrollment :||654 participants|
|Official Title:||Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||January 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
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
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.
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.
- 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 [ Time Frame: 6 months ]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.
- Hospitalization, surgery, steroid or biologic use [ Time Frame: 6 months ]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.
- Proportion of subjects who underwent an escalation of therapy [ Time Frame: 6 months ]Choice of therapy for all patients should be according to the standard of care and by the judgement of the attending physician.
- Quality of life measured by SIBDQ questionnaire [ Time Frame: 6 months ]
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).
- Quality of life measured by EQ-5D 5L questionnaire [ Time Frame: 6 months ]
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.
- Number of physician visits [ Time Frame: 6 months ]Participants will be asked the number of physician visits during the course of the study.
- Time lost from work or school [ Time Frame: 6 months ]Participants will be asked about time lost from work or school because of ulcerative colitis symptoms.
- Correlation of fecal calprotectin with endoscopic activity [ Time Frame: 6 months ]Endoscopic disease activity is measured by Mayo score. The Mayo Endoscopic Score is classified into the following four categories: 0, normal mucosa or inactive disease; 1, mild disease with erythema, decreased vascular patterns and mild friability; 2, moderate disease with marked erythema, absence of vascular patterns, friability and erosions; 3, severe disease with spontaneous bleeding and ulceration.
- Correlation of fecal calprotectin with histologic disease activity [ Time Frame: 6 months ]
A histologic scoring index is a system used to assess the patient's disease severity using tissue sample. In this study, the Robarts Histology Index (RHI) is used. The RHI can be calculated as 1 x chronic inflammatory infiltrate (4 levels) plus 2 x lamina propria neutrophils (4 levels) plus 3 x neutrophils in epithelium (4 levels) plus 5 x erosion or ulceration (4 levels after combining Geboes 5:1 and 5:2).
Score takes into consideration histologic variables like crypt abscesses, presence of granulation tissue or aggregates of inflammatory elements in the superficial part of the mucosa, indicative of erosions or ulcers, neutrophils in the lamina propria.
- Successful use of IBDoc [ Time Frame: 2 months ]Successful use of IBDoc home test kits will be measured by the completed test reported in the IBDoc portal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549988
|Contact: Maria Schmit, RN||604-688-6332 ext email@example.com|
|Contact: Gregory Rosenfeld, MD||604-688-6332 ext firstname.lastname@example.org|
|Canada, British Columbia|
|Pacific Gastroenterology Associates||Recruiting|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|Contact: Maria Schmit 604-688-6332 ext 235 email@example.com|
|Principal Investigator: Greg Rosenfeld, MD|
|Principal Investigator:||Gregory Rosenfeld, MD||University of British Columbia, Depart. of Medicine, Div. of Gastroenterology|