Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Other: Fecal Calprotectin (FC) measurements with IBDocTM

• Registration Number: NCT03549988
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Study Start: 2018-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 726

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

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Exclusion Criteria

• Patients experiencing a symptomatic flare
• Patients currently receiving therapy as part of a clinical trial
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention: FC measurements with IBDoc	Fecal Calprotectin (FC) measurements with IBDocTM	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who underwent an escalation of therapy	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	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).
Hospitalization, surgery, steroid or biologic use	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.
Correlation of fecal calprotectin with endoscopic activity	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.
Quality of life measured by EQ-5D 5L questionnaire	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.
Time lost from work or school	6 months	Participants will be asked about time lost from work or school because of ulcerative colitis symptoms.
Correlation of fecal calprotectin with histologic disease activity	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.
Number of physician visits	6 months	Participants will be asked the number of physician visits during the course of the study.
Successful use of IBDoc	2 months	Successful use of IBDoc home test kits will be measured by the completed test reported in the IBDoc portal.

Trial Locations

Locations (1)

Pacific Gastroenterology Associates; 🇨🇦 Vancouver, British Columbia, Canada