Ulcerative ColitisNCT01852760
Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound
An observational study of Ulcerative Colitis and Inflammatory Bowel Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
In this cross-sectional study patients with active or quiescent ulcerative colitis will be studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood flow and thickness as reliable indices of disease severity and the degree of correlation that exists with validated clinical… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jul 2015
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients with IBD attending outpatient IBD clinics at the University of Western Ontario teaching hospitals and patients admitted to hospital with severe UC will be included for endoscopic ultrasound assessment.
Who may be able to join
- Patients with a confirmed diagnosis of ulcerative colitis aged 18-85
- Patients termed either "active" or "inactive" UC
- Patients may be treatment naïve (ie: new diagnosis) or on existing therapy including 5'ASA (oral or topical), AZA, corticosteroids, or IFX
Who cannot join
- Inability to or unwillingness to undergo flexible sigmoidoscopy or colonoscopy
- Inability to provide informed consent
- Crohn's disease 4. Presence of an ileoanal pouch
Trial locations and contacts
1 site in 1 country.
About this study
In this cross-sectional study patients with active or quiescent ulcerative colitis will be studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood flow and thickness as reliable indices of disease severity and the degree of correlation that exists with validated clinical, endoscopic, and histological indices.
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of unknown etiology characterized by diffuse mucosal inflammation limited to the colon. The basis of medical treatment is with agents that reduce the inflammatory process. Tailoring appropriate therapy will depend on disease severity, which can be difficult to identify. A response to therapy may also require months to determine. Medications for induction of remission and/or for maintenance in patients with mild to severe UC include 5-aminosalicylates (5'ASA), corticosteroids, azathioprine (AZA), cyclosporine, and infliximab (IFX). All medications have their own inherent side effect profile. Cost can be a major issue with some medications such as IFX, which can be tens of thousands of dollars annually. Medical management can still fail in those with severe disease necessitating surgical management with a colectomy. Identification of high-risk patients who are candidates for more intensive therapy early in the disease course might be a strategy to improve treatment outcomes and limit cost.
This notion of "individualizing" therapy is attractive and a distinct departure from the current "step-care" paradigm in which treatments are added sequentially on the basis of symptom-defined treatment failure. However, for this paradigm to be implementable an objective means of accurately stratifying risk must be identified and validated. Accordingly, increased interest has evolved in the use of biomarkers as prognostic tools. Although fecal calprotectin and serum CRP are potential candidates for this role, these tests have limitations.
Transabdominal ultrasound (US) has been used in the diagnostic workup of IBD. US was a good surrogate of disease activity when compared to colonoscopy, but is unable to reliably assess the rectal wall which tends to cause the most symptoms in UC. Endoscopic ultrasound (EUS) is a highly accurate diagnostic modality for the assessment of rectal pathology. However, the role of EUS in IBD is not well defined. Tsuga et al showed total wall thickness to be highly predictive for acute inflammation in patients with UC compared to healthy controls and that the degree of rectal wall involvement correlated with endoscopic severity. Higaki et al showed patients with quiescent UC who relapsed had initial sonographic evidence of "deep" disease activity shown by significantly greater baseline thickness of the first 3 layers of the rectal wall. Yoshizawa et al subsequently demonstrated that inflammation reaching the muscularis propria or deeper predicted the need for colectomy. Hurlstone et al correlated EUS scores with histopathology, endoscopic, and clinical scores and found good concordance to only exist with superficial EUS scores. In all of these studies the investigators who performed the EUS analysis did so with knowledge of the endoscopy scores. This questions the validity of these results due to the potential for bias. Another parameter that shows promise for evaluation of inflammatory burden is EUS evaluation of blood flow. Surprisingly, Doppler flow has not been used to assess bowel wall vascularity in UC with EUS. We believe that assessment of vascularity has the potential to differentiate with a high degree of accuracy active from quiescent disease.
Although the existing literature indicates that EUS has potential as an evaluative and prognostic tool the investigators believe that a great deal of additional research is needed to further develop this technology. This study will correlate Doppler EUS and other EUS indices with validated clinical, endoscopic, and histological indices of UC inflammation to assess its utility as a diagnostic tool. It will assess the reproducibility of these indices by calculating inter and intra-observer agreement by blinded expert reviewers. This information may have prognostic importance and might ultimately be used to guide therapy in individual patients.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- endoscopic ultrasound, ulcerative colitis, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UC in Remission | Patients with UC in remission | |
| UC Mild Disease | Patients with mild UC disease activity based on partial Mayo Score | |
| UC Moderate to severe | Patients with ulcerative colitis with moderate to severe disease activity based on partial Mayo score |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC
The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC
Measured: 1 day
Secondary outcomes (3)
Interobserver variability of endoscopic and histologic scores
The agreement by raters of endoscopic and histologic scores of inflammation in UC using the intra-rater and inter-rater reliability.
Measured: 1 day
Interobserver variability of EUS Indices
The agreement by rater's of EUS indices of inflammation using the intra-rater and inter-rater reliability.
Measured: 1 day
Hyperemia score correlation with UC disease activity
Hyperemia on Doppler EUS to assess inflammatory changes in UC patients with active inflammation compared to quiescent disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Calgary, University of Toronto, Dalhousie University
- Responsible party
- Principal investigator, Brian Yan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brian Yan, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852760
- Sponsor's protocol ID
- UWO103563
- Status last verified
- Oct 2015
- First submitted
- 7 May 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.
PubMed 19997096Tsuga K, Haruma K, Fujimura J, Hata J, Tani H, Tanaka S, Sumii K, Kajiyama G. Evaluation of the colorectal wall in normal subjects and patients with ulcerative colitis using an ultrasonic catheter probe. Gastrointest Endosc. 1998 Nov;48(5):477-84. doi: 10.1016/s0016-5107(98)70088-4.
PubMed 9831835Higaki S, Nohara H, Saitoh Y, Akazawa A, Yanai H, Yoshida T, Okita K. Increased rectal wall thickness may predict relapse in ulcerative colitis: a pilot follow-up study by ultrasonographic colonoscopy. Endoscopy. 2002 Mar;34(3):212-9. doi: 10.1055/s-2002-20293.
PubMed 11870572Yoshizawa S, Kobayashi K, Katsumata T, Saigenji K, Okayasu I. Clinical usefulness of EUS for active ulcerative colitis. Gastrointest Endosc. 2007 Feb;65(2):253-60. doi: 10.1016/j.gie.2005.10.037.
PubMed 17258984Hurlstone DP, Sanders DS, Lobo AJ, McAlindon ME, Cross SS. Prospective evaluation of high-frequency mini-probe ultrasound colonoscopic imaging in ulcerative colitis: a valid tool for predicting clinical severity. Eur J Gastroenterol Hepatol. 2005 Dec;17(12):1325-31. doi: 10.1097/00042737-200512000-00010.
PubMed 16292085D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
PubMed 17258735Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lemann M, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Bernhardt CA, Mary JY, Sandborn WJ. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012 Apr;61(4):535-42. doi: 10.1136/gutjnl-2011-300486. Epub 2011 Oct 13.
PubMed 21997563Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000 Sep;47(3):404-9. doi: 10.1136/gut.47.3.404.
PubMed 10940279Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004 Jul;99(7):1371-85. doi: 10.1111/j.1572-0241.2004.40036.x.
PubMed 15233681Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available.
PubMed 16530532Langhorst J, Elsenbruch S, Koelzer J, Rueffer A, Michalsen A, Dobos GJ. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol. 2008 Jan;103(1):162-9. doi: 10.1111/j.1572-0241.2007.01556.x. Epub 2007 Oct 4.
PubMed 17916108Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, Yeung E, Yong E, Haig A, Sey M, Stitt L, Zou GY, Jairath V. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1079-1087. doi: 10.1016/j.gie.2017.07.035. Epub 2017 Jul 29.
PubMed 28760533
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound
- ClinicalTrials.gov ID
- NCT01852760
- Acronym / sponsor ID
- UWO103563
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- endoscopic ultrasound, ulcerative colitis, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Calgary, University of Toronto, Dalhousie University
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 May 2013 (estimated)
- 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.
In this cross-sectional study patients with active or quiescent ulcerative colitis will be studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood flow and thickness as reliable indices of disease severity and the degree of correlation that exists with validated clinical, endoscopic, and histological indices.
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of unknown etiology characterized by diffuse mucosal inflammation limited to the colon. The basis of medical treatment is with agents that reduce the inflammatory process. Tailoring appropriate therapy will depend on disease severity, which can be difficult to identify. A response to therapy may also require months to determine. Medications for induction of remission and/or for maintenance in patients with mild to severe UC include 5-aminosalicylates (5'ASA), corticosteroids, azathioprine (AZA), cyclosporine, and infliximab (IFX). All medications have their own inherent side effect profile. Cost can be a major issue with some medications such as IFX, which can be tens of thousands of dollars annually. Medical management can still fail in those with severe disease necessitating surgical management with a colectomy. Identification of high-risk patients who are candidates for more intensive therapy early in the disease course might be a strategy to improve treatment outcomes and limit cost.
This notion of "individualizing" therapy is attractive and a distinct departure from the current "step-care" paradigm in which treatments are added sequentially on the basis of symptom-defined treatment failure. However, for this paradigm to be implementable an objective means of accurately stratifying risk must be identified and validated. Accordingly, increased interest has evolved in the use of biomarkers as prognostic tools. Although fecal calprotectin and serum CRP are potential candidates for this role, these tests have limitations.
Transabdominal ultrasound (US) has been used in the diagnostic workup of IBD. US was a good surrogate of disease activity when compared to colonoscopy, but is unable to reliably assess the rectal wall which tends to cause the most symptoms in UC. Endoscopic ultrasound (EUS) is a highly accurate diagnostic modality for the assessment of rectal pathology. However, the role of EUS in IBD is not well defined. Tsuga et al showed total wall thickness to be highly predictive for acute inflammation in patients with UC compared to healthy controls and that the degree of rectal wall involvement correlated with endoscopic severity. Higaki et al showed patients with quiescent UC who relapsed had initial sonographic evidence of "deep" disease activity shown by significantly greater baseline thickness of the first 3 layers of the rectal wall. Yoshizawa et al subsequently demonstrated that inflammation reaching the muscularis propria or deeper predicted the need for colectomy. Hurlstone et al correlated EUS scores with histopathology, endoscopic, and clinical scores and found good concordance to only exist with superficial EUS scores. In all of these studies the investigators who performed the EUS analysis did so with knowledge of the endoscopy scores. This questions the validity of these results due to the potential for bias. Another parameter that shows promise for evaluation of inflammatory burden is EUS evaluation of blood flow. Surprisingly, Doppler flow has not been used to assess bowel wall vascularity in UC with EUS. We believe that assessment of vascularity has the potential to differentiate with a high degree of accuracy active from quiescent disease.
Although the existing literature indicates that EUS has potential as an evaluative and prognostic tool the investigators believe that a great deal of additional research is needed to further develop this technology. This study will correlate Doppler EUS and other EUS indices with validated clinical, endoscopic, and histological indices of UC inflammation to assess its utility as a diagnostic tool. It will assess the reproducibility of these indices by calculating inter and intra-observer agreement by blinded expert reviewers. This information may have prognostic importance and might ultimately be used to guide therapy in individual patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UC in Remission | – | –Patients with UC in remission |
| UC Mild Disease | – | –Patients with mild UC disease activity based on partial Mayo Score |
| UC Moderate to severe | – | –Patients with ulcerative colitis with moderate to severe disease activity based on partial Mayo score |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients with IBD attending outpatient IBD clinics at the University of Western Ontario teaching hospitals and patients admitted to hospital with severe UC will be included for endoscopic ultrasound assessment.
Key inclusion criteria (3 listed)
- Patients with a confirmed diagnosis of ulcerative colitis aged 18-85
- Patients termed either "active" or "inactive" UC
- Patients may be treatment naïve (ie: new diagnosis) or on existing therapy including 5'ASA (oral or topical), AZA, corticosteroids, or IFX
Key exclusion criteria (3 listed)
- Inability to or unwillingness to undergo flexible sigmoidoscopy or colonoscopy
- Inability to provide informed consent
- Crohn's disease 4. Presence of an ileoanal pouch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC
Time frame: 1 day
The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC
3 secondary outcomes
Interobserver variability of endoscopic and histologic scores
Time frame: 1 day
Interobserver variability of EUS Indices
Time frame: 1 day
Hyperemia score correlation with UC disease activity
Time frame: 1 day
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 2 Oct 2015.
- Background: PubMed 19997096Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.
- Background: PubMed 9831835Tsuga K, Haruma K, Fujimura J, Hata J, Tani H, Tanaka S, Sumii K, Kajiyama G. Evaluation of the colorectal wall in normal subjects and patients with ulcerative colitis using an ultrasonic catheter probe. Gastrointest Endosc. 1998 Nov;48(5):477-84. doi: 10.1016/s0016-5107(98)70088-4.
- Background: PubMed 11870572Higaki S, Nohara H, Saitoh Y, Akazawa A, Yanai H, Yoshida T, Okita K. Increased rectal wall thickness may predict relapse in ulcerative colitis: a pilot follow-up study by ultrasonographic colonoscopy. Endoscopy. 2002 Mar;34(3):212-9. doi: 10.1055/s-2002-20293.
- Background: PubMed 17258984Yoshizawa S, Kobayashi K, Katsumata T, Saigenji K, Okayasu I. Clinical usefulness of EUS for active ulcerative colitis. Gastrointest Endosc. 2007 Feb;65(2):253-60. doi: 10.1016/j.gie.2005.10.037.
- Background: PubMed 16292085Hurlstone DP, Sanders DS, Lobo AJ, McAlindon ME, Cross SS. Prospective evaluation of high-frequency mini-probe ultrasound colonoscopic imaging in ulcerative colitis: a valid tool for predicting clinical severity. Eur J Gastroenterol Hepatol. 2005 Dec;17(12):1325-31. doi: 10.1097/00042737-200512000-00010.
- Background: PubMed 17258735D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
- Background: PubMed 21997563Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lemann M, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Bernhardt CA, Mary JY, Sandborn WJ. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012 Apr;61(4):535-42. doi: 10.1136/gutjnl-2011-300486. Epub 2011 Oct 13.
- Background: PubMed 10940279Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000 Sep;47(3):404-9. doi: 10.1136/gut.47.3.404.
- Background: PubMed 15233681Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004 Jul;99(7):1371-85. doi: 10.1111/j.1572-0241.2004.40036.x.
- Background: PubMed 16530532Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available.
- Background: PubMed 17916108Langhorst J, Elsenbruch S, Koelzer J, Rueffer A, Michalsen A, Dobos GJ. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol. 2008 Jan;103(1):162-9. doi: 10.1111/j.1572-0241.2007.01556.x. Epub 2007 Oct 4.
- Derived from this study: PubMed 28760533Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, Yeung E, Yong E, Haig A, Sey M, Stitt L, Zou GY, Jairath V. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1079-1087. doi: 10.1016/j.gie.2017.07.035. Epub 2017 Jul 29.
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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.
Brian Yan, MD principal investigator
Western University
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 and Inflammatory Bowel Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 3 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 2 Oct 2015. 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 correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC (time frame: 1 day). 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 NCT01852760, which also lists 12 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 2 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.