Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

Completed

• Conditions: Disease Exacerbation; Cytomegalovirus Infections; Ulcerative Colitis

• Registration Number: NCT02439372
• Lead Sponsor: Asan Medical Center

Brief Summary

Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

Detailed Description

Moderate to severe ulcerative colitis patients admitted in Inflammatory Bowel Disease (IBD) center will be enrolled in this study. Eligible patients had active UC with a Mayo score of 6-12 points (moderate or severe disease activity). The investigators will evaluate whether CMV-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• moderate to severe UC require hospitalization
• age 16 or more
• agree with written informed consent

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Exclusion Criteria

• pregnancy
• foreign
• immunosuppressed patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV infection	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	CMV colitis (CMV disease involving the colon) was diagnosed by colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) in accordance with current European guidelines

Secondary Outcome Measures

Name	Time	Method
Breakthrough CMV infection	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Breakthrough CMV colitis was diagnosed by newly positive colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) at the time of second colonic biopsy
Viral clearance from colonic mucosa	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Viral clearance from colonic mucosa was diagnosed as negative by immunohistochemistry (IHC) after a ganciclovir treatment

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of