Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | April 2005 |
| End Date: | June 2012 |
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.
disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD,
whereas their absence would preclude such association.
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.
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.
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.
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