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Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease - NCT00222378-33136(Clinical Trial 130921)



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City:  Miami
State:  
FL
Zip Code: 33136
Conditions: Crohn's Disease - Ulcerative Colitis
Purpose: 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.
Study summary: 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.
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.
Study is available at: Jackson Memorial Hospital
Miami, FL 33136
United States

Primary Contact:
Paul A Feldman, M.D., M.Sc
Email: pfeldman@um-jmh.org
Phone: 305-585-5126

Secondary Contact:
Paul A Feldman, M.D., M.Sc.
Email: pfeldman@um-jmh.org
Phone: 305 585-5126
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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