Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

NCT02684734 | Completed

• 1 other identifier: H15-00197
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Ulcerative Colitis; Cytomegalovirus Infections

Keywords

Ulcerative Colitis; UC; Cytomegalovirus; CMV

Outcome Measures

Primary Outcomes (1)

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

  upon enrollment

Secondary Outcomes (7)

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

  upon enrollment

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

  1 year

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

  1 year

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

  1 year

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

  1 year

Study Arms (2)

Patients on no immunosuppressant

This includes patients on no medication or mesalamine.

Patients on immunosuppressants

This 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.

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (9)

• 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.

  PMID: 21172262 BACKGROUND

• 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.

  PMID: 18452205 BACKGROUND

• 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.

  PMID: 16954807 BACKGROUND

• 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.

  PMID: 21552140 BACKGROUND

• 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.

  PMID: 15496396 BACKGROUND

• 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.

  PMID: 21788989 BACKGROUND

• 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.

  PMID: 21879802 BACKGROUND

• 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.

  PMID: 17828781 BACKGROUND

• 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.

  PMID: 26273816 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and tissue

MeSH Terms

Conditions

Colitis, Ulcerative; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Brian Bressler, MD

  Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 18, 2016
• Study Start: December 1, 2015
• Primary Completion: November 30, 2019
• Study Completion: December 1, 2019
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)