Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02684734
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE-UC
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: