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

University of Miami logo

University of Miami

Status

Completed

Conditions

Ulcerative Colitis
Crohn's Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00222378
20043510
Protocol VAL094
WIRB® Protocol #20050561 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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