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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00222378

Enrollment

129

Registered

2005-09-22

Start date

2005-04-30

Completion date

2012-06-30

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Crohn's disease, ulcerative colitis, cytomegalovirus, Epstein Bar Virus, Human Herpes virus 6

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease	0
Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue versus non inflamed tissues from Patients with Mild to Moderate Inflammatory.	0
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	0

Countries

United States

Outcome results