GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 2K5, Canada
NCT Number: NCT02684734
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
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Notify Me19 year and older
All sexes
Observational
Vancouver, British Columbia, V6Z 2K5, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: upon enrollment
Time frame: upon enrollment
This will be measured by serum immunoglobulin M (IgM)
Time frame: 1 year
This will be measured by serum immunoglobulin G (IgG)
Time frame: 1 year
This will be measured by viral load in the serum.
Time frame: 1 year
This will be measured by colonic biopsy CMV polymerase chain reaction (PCR)
Time frame: 1 year
This will be measured histopathologically with CMV immunochemistry staining.
Time frame: upon enrollment
Time frame: 1 year
University of British Columbia
Other
Acronym: PROVE-UC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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