Clinical trial NCT02684734: Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis
Official title: Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Cytomegalovirus Infections
Keywords: Ulcerative Colitis
UC
Cytomegalovirus
CMV
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of CMV infection (ie previous CMV exposure or existing CMV virus) in patients with quiescent UC undergoing routine surveillance endoscopy
timeFrame: upon enrollment
Secondary outcomes:
measure: Prevalence of cytomegalovirus (CMV) viremia (ie. active virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy
timeFrame: upon enrollment
measure: Prevalence of CMV (ie. inactive virus in bloodstream) in patients with quiescent UC receiving immunosuppressive therapy
timeFrame: 1 year
measure: Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy
timeFrame: 1 year
measure: Prevalence of cytomegalovirus (CMV) infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.
timeFrame: 1 year
measure: Prevalence of CMV infection of the colon in patients with quiescent UC receiving immunosuppressive therapy.
timeFrame: 1 year
measure: Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC
timeFrame: upon enrollment
measure: Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GI Clinic, St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC, Canada
name: Brian Bressler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayre K, Warren BF, Jeffery K, Travis SP. The role of CMV in steroid-resistant ulcerative colitis: A systematic review. J Crohns Colitis. 2009 Sep;3(3):141-8. doi: 10.1016/j.crohns.2009.03.002. Epub 2009 Apr 14.
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citation: Sipponen T, Turunen U, Lautenschlager I, Nieminen U, Arola J, Halme L. Human herpesvirus 6 and cytomegalovirus in ileocolonic mucosa in inflammatory bowel disease. Scand J Gastroenterol. 2011 Nov;46(11):1324-33. doi: 10.3109/00365521.2011.605466. Epub 2011 Aug 31.
citation: Yoshino T, Nakase H, Ueno S, Uza N, Inoue S, Mikami S, Matsuura M, Ohmori K, Sakurai T, Nagayama S, Hasegawa S, Sakai Y, Chiba T. Usefulness of quantitative real-time PCR assay for early detection of cytomegalovirus infection in patients with ulcerative colitis refractory to immunosuppressive therapies. Inflamm Bowel Dis. 2007 Dec;13(12):1516-21. doi: 10.1002/ibd.20253.
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