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

NCT ID: NCT02439372

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-06-30

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).

Conditions

Ulcerative Colitis; Cytomegalovirus Infections; Disease Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• foreign
• immunosuppressed patients

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Han Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Han Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Jung KH, Kim J, Lee HS, Choi J, Jang SJ, Jung J, Kim MJ, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Park SH, Yang DH, Ye BD, Yang SK, Kim SH. Clinical Implications of the CMV-Specific T-Cell Response and Local or Systemic CMV Viral Replication in Patients With Moderate to Severe Ulcerative Colitis. Open Forum Infect Dis. 2019 Dec 18;6(12):ofz526. doi: 10.1093/ofid/ofz526. eCollection 2019 Dec.

Reference Type: DERIVED

PMID: 31893211 (View on PubMed)

Other Identifiers

Report Number 2015-0129

Identifier Type: -

Identifier Source: org_study_id