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Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

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ClinicalTrials.gov Identifier: NCT03549988
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Greg Rosenfeld, 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.


Condition or disease Intervention/treatment
Ulcerative Colitis Other: Fecal Calprotectin (FC) measurements with IBDocTM

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.


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Study Type : Observational
Estimated Enrollment : 654 participants
Observational Model: Other
Time Perspective: Prospective
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 : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control

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 (MMAS-8, 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 (MMAS-8, 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.





Primary Outcome Measures :
  1. The time to a symptomatic flare, defined as an increase in 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.


Secondary Outcome Measures :
  1. 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.

  2. Medical adherence [ Time Frame: 6 months ]
    Medical adherence is measured by completing the on-line Morisky Medication Adherence Scale (MMAS-8) questionnaire and patient report number of missed medication doses. Scale consist of 8 questions answerable by yes/no. Single point score is assigned to each question answered "no" to questions 1-3 and 6-7. A point is given in question 5 for an answer of "yes." Question 8 has a five- point Likert response scale. Total scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.

  3. 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.

  4. 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).


  5. 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.


  6. Number of physician visits [ Time Frame: 6 months ]
    Participants will be asked the number of physician visits during the course of the study.

  7. 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.

  8. 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.

  9. 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.


  10. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will consit of 654 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.
Criteria

Inclusion Criteria:

  • Patients age 19 years or older with Ulcerative Colitis
  • Symptomatic remission defined as a Partial Mayo score ≤ 1 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

Information from the National Library of Medicine

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


Contacts
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Contact: Maria Schmit, RN 604-688-6332 ext 235 maria.a.schmit@gmail.com
Contact: Gregory Rosenfeld, MD 604-688-6332 ext 223 greg.rosenfeld@ubc.ca

Locations
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Canada, British Columbia
Pacific Gastroenterology Associates Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Maria Schmit    604-688-6332 ext 235    maria.a.schmit@gmail.com   
Principal Investigator: Greg Rosenfeld, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Gregory Rosenfeld, MD University of British Columbia, Depart. of Medicine, Div. of Gastroenterology

Additional Information:
Publications:

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Responsible Party: Greg Rosenfeld, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03549988     History of Changes
Other Study ID Numbers: H18-00647
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Greg Rosenfeld, University of British Columbia:
Ulcerative colitis
Fecal calprotectin

Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases