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

Ulcerative Colitis Clinical Trial

— ACE-UC  

Official title:

Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis (ACE-UC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439372
• Other study ID #: Report Number 2015-0129
• Status: Completed
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• moderate to severe UC require hospitalization

• age 16 or more

• agree with written informed consent

Exclusion Criteria:

• pregnancy

• foreign

• immunosuppressed patients

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Cytomegalovirus Infections
• Disease Exacerbation
• Disease Progression
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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