Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222378
• Other study ID #: 20043510
• Secondary ID: Protocol VAL094W
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: July 28, 2015
• Start date: April 2005
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cottone M, Pietrosi G, Martorana G, Casà 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. — View Citation

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. Review. — View Citation

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. — View Citation

Probert CS, Hearing SD, Schreiber S, Kühbacher 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease		0	No
Primary	Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue versus non inflamed tissues from Patients with Mild to Moderate Inflammatory.		0	No
Primary	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		0	No