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AzTrials

Crohn's DiseaseNCT00222378

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

An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn's Disease, Ulcerative Colitis
How many people
129 participants
Where
1 siteUnited States
Study dates
Apr 2005to Jun 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jackson Memorial Hospital

    Miami, Florida, 33136

Other trials in United States

About this study

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

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.

Read the 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 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.
Keywords
Crohn's disease, ulcerative colitis, cytomegalovirus, Epstein Bar Virus, Human Herpes virus 6
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 0

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

    Measured: 0

  3. 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

    Measured: 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00222378
Sponsor's protocol ID
20043510
Other IDs
Protocol VAL094, WIRB® Protocol #20050561
Status last verified
May 2015
First submitted
19 Sep 2005
Last updated
30 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 1287131

  • 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.

    PubMed 2859801

  • 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.

    PubMed 8724263

  • 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.

    PubMed 11693350

  • 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.

    PubMed 2177863

  • 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.

    PubMed 192627

  • 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.

    PubMed 222233

  • 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.

    PubMed 11280549

  • 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.

    PubMed 11774988

  • 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.

    PubMed 14530660

  • 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.

    PubMed 15104299

  • 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.

    PubMed 12801957

  • 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.

    PubMed 11816543

  • 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.

    PubMed 10880375

  • 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.

    PubMed 10364028

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Cytomegalovirus and Epstein Barr Virus in Patients with Mild to Moderate Inflammatory Bowel Disease compared to patients without inflammatory bowel disease (time frame: 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00222378, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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