Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Ulcerative Colitis Clinical Trial

Official title:

Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03549988
• Other study ID #: H18-00647
• Status: Active, not recruiting
• Start date: December 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 726
• Est. completion date: December 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Canada	Pacific Gastroenterology Associates	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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. — View Citation

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. — View Citation

Bernstein CN, Wajda A, Svenson LW, MacKenzie A, Koehoorn M, Jackson M, Fedorak R, Israel D, Blanchard JF. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol. 2006 Jul;101(7):1559-68. doi: 10.1111/j.1572-0241.2006.00603.x. Erratum In: Am J Gastroenterol. 2006 Aug;101(8):1945. — View Citation

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. — View Citation

Costa F, Mumolo MG, Ceccarelli L, Bellini M, Romano MR, Sterpi C, Ricchiuti A, Marchi S, Bottai M. Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut. 2005 Mar;54(3):364-8. doi: 10.1136/gut.2004.043406. — View Citation

Feagan BG, Macdonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000543. doi: 10.1002/14651858.CD000543.pub3. — View Citation

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. Erratum In: Clin Gastroenterol Hepatol. 2018 Feb;16(2):302. — View Citation

Jowett SL, Seal CJ, Barton JR, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2921-8. doi: 10.1111/j.1572-0241.2001.04682.x. — View Citation

Kopylov U, Rosenfeld G, Bressler B, Seidman E. Clinical utility of fecal biomarkers for the diagnosis and management of inflammatory bowel disease. Inflamm Bowel Dis. 2014 Apr;20(4):742-56. doi: 10.1097/01.MIB.0000442681.85545.31. — View Citation

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. — View Citation

Rocchi A, Benchimol EI, Bernstein CN, Bitton A, Feagan B, Panaccione R, Glasgow KW, Fernandes A, Ghosh S. Inflammatory bowel disease: a Canadian burden of illness review. Can J Gastroenterol. 2012 Nov;26(11):811-7. doi: 10.1155/2012/984575. — View Citation

Rosenfeld G, Greenup AJ, Round A, Takach O, Halparin L, Saadeddin A, Ho JK, Lee T, Enns R, Bressler B. FOCUS: Future of fecal calprotectin utility study in inflammatory bowel disease. World J Gastroenterol. 2016 Sep 28;22(36):8211-8. doi: 10.3748/wjg.v22.i36.8211. — View Citation

Roseth AG, Aadland E, Jahnsen J, Raknerud N. Assessment of disease activity in ulcerative colitis by faecal calprotectin, a novel granulocyte marker protein. Digestion. 1997;58(2):176-80. doi: 10.1159/000201441. — View Citation

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. — View Citation

Zhulina Y, Cao Y, Amcoff K, Carlson M, Tysk C, Halfvarson J. The prognostic significance of faecal calprotectin in patients with inactive inflammatory bowel disease. Aliment Pharmacol Ther. 2016 Sep;44(5):495-504. doi: 10.1111/apt.13731. Epub 2016 Jul 12. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	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.	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	Number of physician visits	Participants will be asked the number of physician visits during the course of the study.	6 months
Secondary	Time lost from work or school	Participants will be asked about time lost from work or school because of ulcerative colitis symptoms.	6 months
Secondary	Correlation of fecal calprotectin with endoscopic activity	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.	6 months
Secondary	Correlation of fecal calprotectin with histologic disease activity	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.	6 months
Secondary	Successful use of IBDoc	Successful use of IBDoc home test kits will be measured by the completed test reported in the IBDoc portal.	2 months

External Links

•   Home smart-phone based measurement of fecal calprotectin by IBD patients: correlation with laboratory assay and applicability as patient-friendly monitoring too, ECCO 2017 Poster 1
•   Raker J., et al., P599 Home testing for faecal calprotectin: follow-up results from the first UK trial, ECCO 2017 Poster