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OpenTrials
Completed

NCT Number: NCT02684734

Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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)

  5. 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.

  6. Correlation of serum CMV status with colonic CMV manifestation in patients with quiescent UC

    Time frame: upon enrollment

  7. Correlation of serum CMV status with colonic CMV manifestation in patients with known latent CMV infection during active UC flare

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: PROVE-UC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2016
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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