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

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University of British Columbia

Status

Completed

Conditions

Ulcerative Colitis
Cytomegalovirus Infections

Study type

Observational

Funder types

Other

Identifiers

NCT02684734
H15-00197

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Patients on no immunosuppressant
Description:
This includes patients on no medication or mesalamine.
Patients on immunosuppressants
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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