Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

An observational study of Ulcerative Colitis, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Ulcerative Colitis
What is being tested?: Fecal Calprotectin (FC) measurements with IBDocTM
How many people: 726 participants
Where: 1 siteCanada
Study dates: 1 Dec 2018to 31 Dec 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Ulcerative Colitis
Being tested: Fecal Calprotectin (FC) measurements with IBDocTM
Keywords: Ulcerative colitis, Fecal calprotectin
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal Calprotectin (FC) measurements with IBDocTMOther
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.

Study groups in NCT03549988
Study group	Role	What they receive
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. Receives: Other: Fecal Calprotectin (FC) measurements with IBDocTM

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (9)

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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Number of physician visits
Participants will be asked the number of physician visits during the course of the study.
Measured: 6 months
Time lost from work or school
Participants will be asked about time lost from work or school because of ulcerative colitis symptoms.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Successful use of IBDoc
Successful use of IBDoc home test kits will be measured by the completed test reported in the IBDoc portal.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201831 Dec 2025

First posted8 Jun 2018
Study start1 Dec 2018
Primary completion30 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 726 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03549988
Sponsor's protocol ID: H18-00647
Status last verified: Apr 2026
First submitted: 5 May 2018
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 16863561
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.
PubMed 23166905
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.
PubMed 9144308
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.
PubMed 15710984
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.
PubMed 24562174
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.
PubMed 27402063
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.
PubMed 27688663
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.
PubMed 20848512
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.
PubMed 11693327
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.
PubMed 24885017
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.
PubMed 26475633
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.
PubMed 25747596
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.
PubMed 28606846
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.
PubMed 28587751
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.
PubMed 23076889

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial
ClinicalTrials.gov ID: NCT03549988
Acronym / sponsor ID: H18-00647
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis, Fecal calprotectin
Study type: Observational
Recruitment status: Completed
Enrolment: 726 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Study start: 1 Dec 2018 (actual)
Primary completion: 30 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 8 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis:

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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	–	Other: Fecal Calprotectin (FC) measurements with IBDocTMFecal 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.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fecal Calprotectin (FC) measurements with IBDocTMEach 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.	Other	Intervention: FC measurements with IBDoc

Primary outcome

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.

9 secondary outcomes

Hospitalization, surgery, steroid or biologic use
Time frame: 6 months
Proportion of subjects who underwent an escalation of therapy
Time frame: 6 months
Quality of life measured by SIBDQ questionnaire
Time frame: 6 months
Quality of life measured by EQ-5D 5L questionnaire
Time frame: 6 months
Number of physician visits
Time frame: 6 months
Time lost from work or school
Time frame: 6 months
Correlation of fecal calprotectin with endoscopic activity
Time frame: 6 months
Correlation of fecal calprotectin with histologic disease activity
Time frame: 6 months
Successful use of IBDoc
Time frame: 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Background: PubMed 16863561Bernstein 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.
Background: PubMed 23166905Rocchi 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.
Background: PubMed 9144308Roseth 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.
Background: PubMed 15710984Costa 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.
Background: PubMed 24562174Kopylov 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.
Background: PubMed 27402063Zhulina 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.
Background: PubMed 27688663Rosenfeld 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.
Background: PubMed 20848512Trindade 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.
Background: PubMed 11693327Jowett 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.
Background: PubMed 24885017Agborsangaya 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.
Background: PubMed 26475633Mosli 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.
Background: PubMed 25747596Bressler 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Rosenfeld, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03549988, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.