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

University of Miami

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00222378

20043510

Protocol VAL094

WIRB® Protocol #20050561 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.