Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

NCT03549988 | Completed

• 1 other identifier: H18-00647
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Fecal calprotectin

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (9)

• Hospitalization, surgery, steroid or biologic use

  6 months

• Proportion of subjects who underwent an escalation of therapy

  6 months

• Quality of life measured by SIBDQ questionnaire

  6 months

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

  6 months

• Number of physician visits

  6 months

Study Arms (2)

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 (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

Interventions

Fecal Calprotectin (FC) measurements with IBDocTM OTHER

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.

Intervention: FC measurements with IBDoc

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of 756 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, Europe and Australia.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (15)

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  PMID: 15710984 BACKGROUND

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  PMID: 24562174 BACKGROUND

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  PMID: 27402063 BACKGROUND

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  PMID: 27688663 BACKGROUND

• Trindade AJ, Ehrlich A, Kornbluth A, Ullman TA. Are your patients taking their medicine? Validation of a new adherence scale in patients with inflammatory bowel disease and comparison with physician perception of adherence. Inflamm Bowel Dis. 2011 Feb;17(2):599-604. doi: 10.1002/ibd.21310.

  PMID: 20848512 BACKGROUND

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  PMID: 11693327 BACKGROUND

• Agborsangaya CB, Lahtinen M, Cooke T, Johnson JA. Comparing the EQ-5D 3L and 5L: measurement properties and association with chronic conditions and multimorbidity in the general population. Health Qual Life Outcomes. 2014 May 16;12:74. doi: 10.1186/1477-7525-12-74.

  PMID: 24885017 BACKGROUND

• Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Shackelton LM, Walker CW, Nelson S, Vandervoort MK, Frisbie V, Samaan MA, Jairath V, Driman DK, Geboes K, Valasek MA, Pai RK, Lauwers GY, Riddell R, Stitt LW, Levesque BG. Development and validation of a histological index for UC. Gut. 2017 Jan;66(1):50-58. doi: 10.1136/gutjnl-2015-310393. Epub 2015 Oct 16.

  PMID: 26475633 BACKGROUND

• Bressler B, Marshall JK, Bernstein CN, Bitton A, Jones J, Leontiadis GI, Panaccione R, Steinhart AH, Tse F, Feagan B; Toronto Ulcerative Colitis Consensus Group. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015 May;148(5):1035-1058.e3. doi: 10.1053/j.gastro.2015.03.001. Epub 2015 Mar 4.

  PMID: 25747596 BACKGROUND

• Heida A, Knol M, Kobold AM, Bootsman J, Dijkstra G, van Rheenen PF. Agreement Between Home-Based Measurement of Stool Calprotectin and ELISA Results for Monitoring Inflammatory Bowel Disease Activity. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1742-1749.e2. doi: 10.1016/j.cgh.2017.06.007. Epub 2017 Jun 10.

  PMID: 28606846 BACKGROUND

• Bello C, Roseth A, Guardiola J, Reenaers C, Ruiz-Cerulla A, Van Kemseke C, Arajol C, Reinhard C, Seidel L, Louis E. Usability of a home-based test for the measurement of fecal calprotectin in asymptomatic IBD patients. Dig Liver Dis. 2017 Sep;49(9):991-996. doi: 10.1016/j.dld.2017.05.009. Epub 2017 May 19.

  PMID: 28587751 BACKGROUND

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  PMID: 23076889 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Gregory Rosenfeld, MD

  University of British Columbia, Depart. of Medicine, Div. of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: June 8, 2018
• Study Start: December 1, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)