Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis (PROVE-UC)

May 18, 2022 updated by: Brian Bressler, University of British Columbia

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

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Clinic, St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients on no immunosuppressant
This includes patients on no medication or mesalamine.
Patients on immunosuppressants
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?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: upon enrollment
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
Time Frame: 1 year
This will be measured by serum immunoglobulin G (IgG)
1 year
Prevalence of CMV viremia in patients with quiescent UC receiving immunosuppressive therapy
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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
Time Frame: upon enrollment
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brian Bressler, MD, Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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