Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222378
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2005-09-19
Brief Title:
Prevalence of Cytomegalovirus Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Prevalence of Cytomegalovirus Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Crohns 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 Crohns 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 Crohns 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 Crohns 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 Crohns 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 Crohns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol VAL094 | None | None | None |
| WIRB Protocol 20050561 | OTHER | WIRB | None |