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

A

Asan Medical Center

Status

Completed

Conditions

Disease Exacerbation
Ulcerative Colitis
Cytomegalovirus Infections

Study type

Observational

Funder types

Other

Identifiers

NCT02439372
Report Number 2015-0129

Details and patient eligibility

About

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.

Full 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).

Enrollment

80 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • foreign
  • immunosuppressed patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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