Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— PROVE-UC  

Official title:

Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684734
• Other study ID #: H15-00197
• Status: Completed
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Communicable Diseases
• Cytomegalovirus Infections
• Infections
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Canada	GI Clinic, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

Domènech E, Vega R, Ojanguren I, Hernández A, Garcia-Planella E, Bernal I, Rosinach M, Boix J, Cabré 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Roblin X, Pillet S, Oussalah A, Berthelot P, Del Tedesco E, Phelip JM, Chambonnière 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy		upon enrollment
Secondary	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)	upon enrollment
Secondary	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)	1 year
Secondary	Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy	This will be measured by viral load in the serum.	1 year
Secondary	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)	1 year
Secondary	Prevalence of CMV infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.	This will be measured histopathologically with CMV immunochemistry staining.	1 year
Secondary	Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC		upon enrollment
Secondary	Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare		1 year