Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Conditions
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Ulcerative Colitis, Cytomegalovirus Infections

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on no immunosuppressant<br>This includes patients on no medication or mesalamine. | |
| Patients on immunosuppressants<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy | This will be measured by viral load in the serum. | 1 year | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, UC, Cytomegalovirus, CMV