Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Completed

• Conditions: Cytomegalovirus Infections; Ulcerative Colitis

• Registration Number: NCT02684734
• Lead Sponsor: University of British Columbia

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

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Primary Completion: 2019-11-30
• Study Completion: 2019-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy	upon enrollment

Secondary Outcome Measures

Name	Time	Method
Prevalence of cytomegalovirus (CMV) viremia (ie. active virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy	upon enrollment	This will be measured by serum immunoglobulin M (IgM)
Prevalence of cytomegalovirus (CMV) infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.	1 year	This will be measured by colonic biopsy CMV polymerase chain reaction (PCR)
Prevalence of CMV (ie. inactive virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy	1 year	This will be measured by serum immunoglobulin G (IgG)
Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy	1 year	This will be measured by viral load in the serum.
Prevalence of CMV infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.	1 year	This will be measured histopathologically with CMV immunochemistry staining.
Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC	upon enrollment
Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare	1 year

Trial Locations

Locations (1)

GI Clinic, St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada