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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02439372
Acronym
ACE-UC
Enrollment
80
Registered
2015-05-08
Start date
2015-04-30
Completion date
2016-06-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infections, Disease Exacerbation, Ulcerative Colitis

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).

Interventions

None listed

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pregnancy * foreign * immunosuppressed patients

Design outcomes

Primary

MeasureTime frameDescription
CMV infectionparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksCMV 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

MeasureTime frameDescription
Viral clearance from colonic mucosaparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksViral clearance from colonic mucosa was diagnosed as negative by immunohistochemistry (IHC) after a ganciclovir treatment
Breakthrough CMV infectionparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksBreakthrough CMV colitis was diagnosed by newly positive colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) at the time of second colonic biopsy

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026