An observational study in Ulcerative Colitis and Cytomegalovirus Infections, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by University of British Columbia · Observational
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
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 50 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of British Columbia is the lead sponsor of 1,310 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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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.
Exclusion Criteria:
This includes patients on no medication or mesalamine.
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.
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
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)
Time frame: 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)
Time frame: 1 year
Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy
This will be measured by viral load in the serum.
Time frame: 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)
Time frame: 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.
Time frame: 1 year
Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC
Time frame: upon enrollment
Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare
Time frame: 1 year
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of British Columbia