Clinical trial NCT00222378: Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
Official title: Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's disease
ulcerative colitis
cytomegalovirus
Epstein Bar Virus
Human Herpes virus 6
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-22
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease (ulcerative colitis and Crohn's Colitis), Other inflammatory conditions of the colon

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease
timeFrame: 0
measure: Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue versus non inflamed tissues from Patients with Mild to Moderate Inflammatory.
timeFrame: 0
measure: 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
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Jeffrey B Raskin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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