Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease

July 28, 2015 updated by: Paul Feldman, University of Miami

Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease

An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD, whereas their absence would preclude such association.

Study Overview

Status

Completed

Conditions

Detailed Description

The protocol is designed to evaluate the following objectives:

  1. The prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in inflamed intestinal mucosa of patients with Crohn's colitis and ulcerative colitis compared to their prevalence in healthy intestinal mucosa of patients not affected by these conditions;
  2. To evaluate the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in the intestinal mucosa of patients with Crohn's colitis and ulcerative colitis compared to that in inflamed mucosa caused by other conditions (non specific colitis);
  3. To compare the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in inflamed and healthy tissue in the same patients with Crohn's colitis and ulcerative colitis;
  4. To determine whether the presence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA detected by nPCR correlates with immunohistochemical detection of viral protein in colonic tissue.
  5. To determine whether the relative viral quantity of CMV, EBV or HHV-6 is related to severity of disease activity.

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with inflammatory bowel disease (ulcerative colitis and Crohn's Colitis), Other inflammatory conditions of the colon

Description

Inclusion Criteria:

  • Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
  • Participants, male or female, aged 18-70, identified as having Crohn's colitis, UC and patients undergoing biopsy for other inflammatory disorders (non specific colitis) and for suspected intestinal malignancy.

Exclusion Criteria:

  • Known human immunodeficiency virus (HIV) infection
  • Post organ transplant patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease
Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue versus non inflamed tissues from Patients with Mild to Moderate Inflammatory.
Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue from patient with mild to moderate IBD as compared to inflamed mucosa from patients with other inflammatory diseases of the colon

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Jeffrey B Raskin, M.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20043510
  • Protocol VAL094
  • WIRB® Protocol #20050561 (Other Identifier: WIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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