Skip to main content
Clinical Trials/NCT03467841
NCT03467841UnknownNot Applicable

Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis

Dr mohammedRmadan hamad0 sites50 target enrollmentStarted: August 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Primary Endpoint
Cytomegalovirus infection in steroid-refractory ulcerative colitis

Study Overview

Brief Summary

Aim of the work

  • To identify the prevalence of CMV infection in patients with steroid-refractory ulcerative colitis.
  • To assess the clinical and endoscopic conditions in these patients.

Detailed Description

Ulcerative colitis (UC) is a chronic inflammatory disorder of the colonic mucosa characterized by recurrent attacks of bloody diarrhea, abdominal cramping and mucosal ulceration that often requires long-term therapy to maintain remission (Fefferman and Farrell 2005). In addition, refractory UC is moderate to severe colitis refractory or intolerant to conventional therapy (steroid-refractory colitis) or immunomodulators (immunomodulator-refractory colitis) that may end at colectomy( Baumgart and Sandborn 2007)(Garud andPeppercorn 2009).

The etiology of UC is unknown; however, genetic and environmental factors and microorganisms may play an important role. Epidemiological and microbiologic studies suggest that enteropathogenic microorganisms play a substantial role in the clinical initiation and relapses of IBD(Johnson. 2012) (Goodman et al. 2015). e.g. active UC has been associated with increased detection rates of Clostridium difficile, cytomegalovirus (CMV).

Cytomegalovirus (CMV) is a double-stranded DNA virus of the Herpesviridae family. After primary infection, the virus is known to maintain a persistent, life-long infection often as a latent form that can be found in several organs or tissues especially in the colon .

Cytomegalovirus infection (CMV) has been described in patients with inflammatory bowel disease (IBD) as a cause of relapse, mainly in those with steroid refractory disease .This infection is also responsible for a more severe clinical course and it may cause death if not treated early Moreover, an improvement of clinical status when antiviral therapy was initiated, suggesting an active role of CMV (Shukla et al. 2015) .

The prevalence of CMV infection in IBD patients is unclear depending on the method of diagnosis used. It was ranged 16 - 34% in patients with moderate-to-severe UC was using serological and histological tests(Kishore et al 2004) (Wada et al. 2003) .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All eligible patients have an established diagnosis of ulcerative colitis, including clinical, endoscopic and histologic assessments. Eligible patients have moderately to severely active disease (total Mayo score, 6 - 12 points), with endoscopy subscore of at least 2 and had inadequate response to or cannot tolerate treatment with at least one of the following: corticosteroids and/or azathioprine or 6-mercaptopurine and/or 5-aminosalicylate-containing medications.

Exclusion Criteria

  • •- Patients with remittent UC
  • •Patients known to have IBD other than ulcerative colitis

Outcomes

Primary Outcomes

Cytomegalovirus infection in steroid-refractory ulcerative colitis

Time Frame: 6 months

identify the prevalence of CMV infection in patients with steroid-refractory ulcerative colitis and assess the clinical and endoscopic conditions in these patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr mohammedRmadan hamad
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr mohammedRmadan hamad

Tropical Medicine and Gastroenterology department Faculty of Medicine Assiut University

Assiut University

Similar Trials

Cytomegalovirus Infection in... | Clinical Trial