AzTrials
AzTrials

Ulcerative ColitisPROVE-UCNCT02684734

Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

An observational study of Ulcerative Colitis and Cytomegalovirus Infections, 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.

Official record
Search all trials

Trial summary

Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and timely detection of active CMV infection or disease with appropriate anti-viral therapy may reduce complications associated with acute… Read more about this study

Who is it for?
Ages 19 years and older
How many people
50 participants
Where
1 siteCanada
Study dates
Dec 2015to Dec 2019
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: All patients with ulcerative colitis presenting for routine elective surveillance endoscopy will be approached for enrolment. Patients will be evaluated by the gastroenterologist at pre-endoscopy clinic visit for eligibility.

Who may be able to join

  • Patients ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy
  • At enrolment: clinical partial Mayo score < 2 prior to endoscopic evaluation
  • At endoscopy: endoscopic Mayo score < 2

Who cannot join

  • Patient age less than 19
  • Clinical partial Mayo score at enrollment ≥ 2
  • Endoscopic Mayo score ≥ 2
  • Overall Mayo score > 5
  • Patients with known current or previous CMV infection
  • Patients with HIV, solid organ or bone marrow transplantation, immunoglobulin deficiency, and who are otherwise immunosuppressed for reasons other than treatment of ulcerative colitis, or
  • Pregnant patients

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • GI Clinic, St. Paul's Hospital

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

About this study

Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and timely detection of active CMV infection or disease with appropriate anti-viral therapy may reduce complications associated with acute UC flare. Limited information is available on the presence of colonic CMV infection in patients with quiescent ulcerative colitis. Prospective studies on factors associated with reactivation of CMV infection during active UC flare and its impact on disease progression are lacking.

The hypothesis of this study are as follows: 1) CMV infection is prevalent in patients with ulcerative colitis irrespective of disease severity; 2) The degree of immunosuppression directly impacts CMV infection status in patients with ulcerative colitis

Read the detailed description

This is cross sectional study at St. Paul's Hospital, a tertiary academic teaching hospital. Subjects ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy will be invited for the study.

At enrollment, subjects will be evaluated for clinical and endoscopic disease severity using Mayo score. To be eligible for the study, Mayo score must be <2. Supplemental blood tests, diagnostic test to determine CMV status, physical examination for extra-intestinal manifestation of CMV and inflammatory bowel disease, and surveillance colonoscopy with colonic biopsy will be done.

Patients will be followed longitudinally. Patients will be contacted every three months via their preferred method (telephone or email) until disease flare (clinical partial Mayo Score > 2) or one year from enrolment. Patients will be asked to contact study coordinator when they are experiencing UC flare.

Keywords
Ulcerative Colitis, UC, Cytomegalovirus, CMV
Medical subject headings
Colitis, Ulcerative, Cytomegalovirus Infections

What participants receive

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

Study groups in NCT02684734
Study groupRoleWhat they receive
Patients on no immunosuppressantThis includes patients on no medication or mesalamine.
Patients on immunosuppressantsThis includes patients on biologics, azathioprine (AZA), 6-mercaptopurine (6-MP), or corticosteroid. These patients will be sub-analyzed to: a) Patients on one immunosuppressive therapy with AZA, 6-MP, biologic or corticosteroid; b) Patients on combination therapy with AZA or 6-MP and biologic; c) Patients on triple therapy with corticosteroid, AZA or 6-MP, and biologic; d) Patients on corticosteroid and one other immunosuppressive therapy such as AZA, 6-MP, or biologic.

What is being measured

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

  1. Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy

    Measured: upon enrollment

Secondary outcomes (7)

  1. Prevalence of cytomegalovirus (CMV) viremia (ie. active virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy

    This will be measured by serum immunoglobulin M (IgM)

    Measured: upon enrollment

  2. Prevalence of CMV (ie. inactive virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy

    This will be measured by serum immunoglobulin G (IgG)

    Measured: 1 year

  3. Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy

    This will be measured by viral load in the serum.

    Measured: 1 year

  4. Prevalence of cytomegalovirus (CMV) infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.

    This will be measured by colonic biopsy CMV polymerase chain reaction (PCR)

    Measured: 1 year

  5. Prevalence of CMV infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.

    This will be measured histopathologically with CMV immunochemistry staining.

    Measured: 1 year

  6. Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC

    Measured: upon enrollment

  7. Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare

    Measured: 1 year

Timeline

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

  1. First posted18 Feb 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion30 Nov 2019
  4. Study completionDec 2019

Resources

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
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684734
Sponsor's protocol ID
H15-00197
Acronym
PROVE-UC
Status last verified
May 2022
First submitted
27 Jan 2016
Last updated
20 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ayre K, Warren BF, Jeffery K, Travis SP. The role of CMV in steroid-resistant ulcerative colitis: A systematic review. J Crohns Colitis. 2009 Sep;3(3):141-8. doi: 10.1016/j.crohns.2009.03.002. Epub 2009 Apr 14.

    PubMed 21172262

  • Domenech E, Vega R, Ojanguren I, Hernandez A, Garcia-Planella E, Bernal I, Rosinach M, Boix J, Cabre E, Gassull MA. Cytomegalovirus infection in ulcerative colitis: a prospective, comparative study on prevalence and diagnostic strategy. Inflamm Bowel Dis. 2008 Oct;14(10):1373-9. doi: 10.1002/ibd.20498.

    PubMed 18452205

  • Dimitroulia E, Spanakis N, Konstantinidou AE, Legakis NJ, Tsakris A. Frequent detection of cytomegalovirus in the intestine of patients with inflammatory bowel disease. Inflamm Bowel Dis. 2006 Sep;12(9):879-84. doi: 10.1097/01.mib.0000231576.11678.57.

    PubMed 16954807

  • Kim YS, Kim YH, Kim JS, Cheon JH, Ye BD, Jung SA, Park YS, Choi CH, Jang BI, Han DS, Yang SK, Kim WH; IBD Study Group of the Korean Association for the Study of Intestinal Diseases. The prevalence and efficacy of ganciclovir on steroid-refractory ulcerative colitis with cytomegalovirus infection: a prospective multicenter study. J Clin Gastroenterol. 2012 Jan;46(1):51-6. doi: 10.1097/MCG.0b013e3182160c9c.

    PubMed 21552140

  • Kishore J, Ghoshal U, Ghoshal UC, Krishnani N, Kumar S, Singh M, Ayyagari A. Infection with cytomegalovirus in patients with inflammatory bowel disease: prevalence, clinical significance and outcome. J Med Microbiol. 2004 Nov;53(Pt 11):1155-1160. doi: 10.1099/jmm.0.45629-0.

    PubMed 15496396

  • Roblin X, Pillet S, Oussalah A, Berthelot P, Del Tedesco E, Phelip JM, Chambonniere ML, Garraud O, Peyrin-Biroulet L, Pozzetto B. Cytomegalovirus load in inflamed intestinal tissue is predictive of resistance to immunosuppressive therapy in ulcerative colitis. Am J Gastroenterol. 2011 Nov;106(11):2001-8. doi: 10.1038/ajg.2011.202. Epub 2011 Jul 26.

    PubMed 21788989

  • Sipponen T, Turunen U, Lautenschlager I, Nieminen U, Arola J, Halme L. Human herpesvirus 6 and cytomegalovirus in ileocolonic mucosa in inflammatory bowel disease. Scand J Gastroenterol. 2011 Nov;46(11):1324-33. doi: 10.3109/00365521.2011.605466. Epub 2011 Aug 31.

    PubMed 21879802

  • Yoshino T, Nakase H, Ueno S, Uza N, Inoue S, Mikami S, Matsuura M, Ohmori K, Sakurai T, Nagayama S, Hasegawa S, Sakai Y, Chiba T. Usefulness of quantitative real-time PCR assay for early detection of cytomegalovirus infection in patients with ulcerative colitis refractory to immunosuppressive therapies. Inflamm Bowel Dis. 2007 Dec;13(12):1516-21. doi: 10.1002/ibd.20253.

    PubMed 17828781

  • McCurdy JD, Enders FT, Jones A, Killian JM, Loftus EV Jr, Bruining DH, Smyrk TC. Detection of Cytomegalovirus in Patients with Inflammatory Bowel Disease: Where to Biopsy and How Many Biopsies? Inflamm Bowel Dis. 2015 Dec;21(12):2833-8. doi: 10.1097/MIB.0000000000000556.

    PubMed 26273816

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis and Cytomegalovirus Infections, 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 3 inclusion and 7 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 20 May 2022. 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?

Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy (time frame: upon enrollment). 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 NCT02684734, which also lists 9 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 20 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in