Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
NCT ID: NCT00222378
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
129 participants
OBSERVATIONAL
2005-04-30
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Post organ transplant patients.
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
University of Miami
OTHER
Responsible Party
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Paul Feldman
Assistant Professor
Principal Investigators
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Jeffrey B Raskin, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Jackson Memorial Hospital
Miami, Florida, United States
Countries
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References
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Wakefield AJ, Fox JD, Sawyerr AM, Taylor JE, Sweenie CH, Smith M, Emery VC, Hudson M, Tedder RS, Pounder RE. Detection of herpesvirus DNA in the large intestine of patients with ulcerative colitis and Crohn's disease using the nested polymerase chain reaction. J Med Virol. 1992 Nov;38(3):183-90. doi: 10.1002/jmv.1890380306.
Berk T, Gordon SJ, Choi HY, Cooper HS. Cytomegalovirus infection of the colon: a possible role in exacerbations of inflammatory bowel disease. Am J Gastroenterol. 1985 May;80(5):355-60.
el-Serag HB, Zwas FR, Cirillo NW, Eisen RN. Fulminant herpes colitis in a patient with Crohn's disease. J Clin Gastroenterol. 1996 Apr;22(3):220-3. doi: 10.1097/00004836-199604000-00015.
Caserta L, Riegler G. Cytomegalovirus and herpes simplex virus antibodies in patients with idiopathic ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):3036-7. doi: 10.1111/j.1572-0241.2001.04690.x. No abstract available.
Riegler G, Piscitelli A, Di Simone A, Esposito C, Sodano G, Tarro G. [Cytomegalovirus and herpes simplex virus antibodies in patients with idiopathic ulcerative rectocolitis]. Minerva Med. 1990 Dec;81(12):861-4. Italian.
Cooper HS, Raffensperger EC, Jonas L, Fitts WT Jr. Cytomegalovirus inclusions in patients with ulcerative colitis and toxic dilation requiring colonic resection. Gastroenterology. 1977 Jun;72(6):1253-6.
Sidi S, Graham JH, Razvi SA, Banks PA. Cytomegalovirus infection of the colon associated with ulcerative colitis. Arch Surg. 1979 Jul;114(7):857-9. doi: 10.1001/archsurg.1979.01370310099019.
Cottone M, Pietrosi G, Martorana G, Casa A, Pecoraro G, Oliva L, Orlando A, Rosselli M, Rizzo A, Pagliaro L. Prevalence of cytomegalovirus infection in severe refractory ulcerative and Crohn's colitis. Am J Gastroenterol. 2001 Mar;96(3):773-5. doi: 10.1111/j.1572-0241.2001.03620.x.
Adani GL, Avital I, Ferraresso C, Aoki T. CMV infection in severe refractory ulcerative and Crohn's colitis. Am J Gastroenterol. 2001 Dec;96(12):3464-5. doi: 10.1111/j.1572-0241.2001.05360.x. No abstract available.
Wada Y, Matsui T, Matake H, Sakurai T, Yamamoto J, Kikuchi Y, Yorioka M, Tsuda S, Yao T, Yao S, Haraoka S, Iwashita A. Intractable ulcerative colitis caused by cytomegalovirus infection: a prospective study on prevalence, diagnosis, and treatment. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S59-65. doi: 10.1097/01.DCR.0000087486.21981.C6.
Kambham N, Vij R, Cartwright CA, Longacre T. Cytomegalovirus infection in steroid-refractory ulcerative colitis: a case-control study. Am J Surg Pathol. 2004 Mar;28(3):365-73. doi: 10.1097/00000478-200403000-00009.
Probert CS, Hearing SD, Schreiber S, Kuhbacher T, Ghosh S, Arnott ID, Forbes A. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial. Gut. 2003 Jul;52(7):998-1002. doi: 10.1136/gut.52.7.998.
Bertalot G, Villanacci V, Gramegna M, Orvieto E, Negrini R, Saleri A, Terraroli C, Ravelli P, Cestari R, Viale G. Evidence of Epstein-Barr virus infection in ulcerative colitis. Dig Liver Dis. 2001 Oct;33(7):551-8. doi: 10.1016/s1590-8658(01)80106-7.
Spieker T, Herbst H. Distribution and phenotype of Epstein-Barr virus-infected cells in inflammatory bowel disease. Am J Pathol. 2000 Jul;157(1):51-7. doi: 10.1016/S0002-9440(10)64516-6.
Yanai H, Shimizu N, Nagasaki S, Mitani N, Okita K. Epstein-Barr virus infection of the colon with inflammatory bowel disease. Am J Gastroenterol. 1999 Jun;94(6):1582-6. doi: 10.1111/j.1572-0241.1999.01148.x.
Other Identifiers
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Protocol VAL094
Identifier Type: -
Identifier Source: secondary_id
WIRB® Protocol #20050561
Identifier Type: OTHER
Identifier Source: secondary_id
20043510
Identifier Type: -
Identifier Source: org_study_id
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