Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy
时间窗: upon enrollment
次要结局
- Prevalence of cytomegalovirus (CMV) viremia (ie. active virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy(upon enrollment)
- Prevalence of cytomegalovirus (CMV) infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.(1 year)
- Prevalence of CMV (ie. inactive virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy(1 year)
- Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy(1 year)
- Prevalence of CMV infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.(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)
研究者
Brian Bressler
Clinical Associate Professor of Medicine
University of British Columbia