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

NCT02439372 | Completed

• 1 other identifier: Report Number 2015-0129
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Cytomegalovirus Infections; Disease Exacerbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Viral clearance from colonic mucosa

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Breakthrough CMV infection

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe ulcerative colitis (Eligible patients had active UC with a Mayo score of 6-12 points)

You may qualify if:

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

You may not qualify if:

• pregnancy
• foreign
• immunosuppressed patients

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31893211 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Cytomegalovirus Infections; Disease Progression

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sung-Han Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

KR (1)