NCT00222378

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 and/or exacerbation of IBD, whereas their absence would preclude such association.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 30, 2015

Status Verified

May 1, 2015

Enrollment Period

7.2 years

First QC Date

September 19, 2005

Last Update Submit

July 28, 2015

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

Crohn's diseaseulcerative colitiscytomegalovirusEpstein Bar VirusHuman Herpes virus 6

Outcome Measures

Primary Outcomes (3)

  • Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease

    0

  • Prevalence of Cytomegalovirus and Epstein Barr Virus in inflamed colonic tissue versus non inflamed tissues from Patients with Mild to Moderate Inflammatory.

    0

  • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inflammatory bowel disease (ulcerative colitis and Crohn's Colitis), Other inflammatory conditions of the colon

You may qualify if:

  • 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.

You may not qualify if:

  • Known human immunodeficiency virus (HIV) infection
  • Post organ transplant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Related Publications (15)

  • 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.

    PMID: 1287131BACKGROUND

  • 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.

    PMID: 2859801BACKGROUND

  • 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.

    PMID: 8724263BACKGROUND

  • 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.

    PMID: 11693350BACKGROUND

  • 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.

    PMID: 2177863BACKGROUND

  • 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.

    PMID: 192627BACKGROUND

  • 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.

    PMID: 222233BACKGROUND

  • 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.

    PMID: 11280549BACKGROUND

  • 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.

    PMID: 11774988BACKGROUND

  • 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.

    PMID: 14530660BACKGROUND

  • 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.

    PMID: 15104299BACKGROUND

  • 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.

    PMID: 12801957BACKGROUND

  • 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.

    PMID: 11816543BACKGROUND

  • 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.

    PMID: 10880375BACKGROUND

  • 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.

    PMID: 10364028BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be discarded upon study completion

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Jeffrey B Raskin, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 30, 2015

Record last verified: 2015-05

Locations

US(1)