- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467841
Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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) .
On the other hand, CMV infection was 20- 40% in those with severely steroid-refractory UC using a combination of antigenemia and histological evaluations (H&E staining and immunohistochemistry [IHC] ( Domenech et al.. 2008)( Maconi et al. 2005) ( Cottone et al.2001)( Kambham et al. 2004 ) In addition, several western studies have tried to explore the implication of CMV reactivation in colonic tissue on the clinical evolution of UC . However, to our knowledge, studies on the relationship between CMV and UC are lacking in our region (Al-Zafiri et al 2012). (Chun et al 2015)(Kim et al 2014) (Wu XW et al.2015).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: mohammed hamad
- Phone Number: 01147647663
- Email: dr.mohomedRamadan@yahoo.com
Study Contact Backup
- Name: Dr Elham hassan
- Phone Number: 01002963415
- Email: mam_elham75@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- You DM, Johnson MD. Cytomegalovirus infection and the gastrointestinal tract. Curr Gastroenterol Rep. 2012 Aug;14(4):334-42. doi: 10.1007/s11894-012-0266-4.
- Goodman AL, Murray CD, Watkins J, Griffiths PD, Webster DP. CMV in the gut: a critical review of CMV detection in the immunocompetent host with colitis. Eur J Clin Microbiol Infect Dis. 2015 Jan;34(1):13-18. doi: 10.1007/s10096-014-2212-x. Epub 2014 Aug 6.
- Kishore J, Ghoshal U, Ghoshal UC, Krishnani N, Kumar S, Singh M, Ayyagari A. Infection with cytomegalovirus in patients with inflammatory bowel disease: prevalence, clinical significance and outcome. J Med Microbiol. 2004 Nov;53(Pt 11):1155-1160. doi: 10.1099/jmm.0.45629-0.
- 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.
- McCurdy JD, Jones A, Enders FT, Killian JM, Loftus EV Jr, Smyrk TC, Bruining DH. A model for identifying cytomegalovirus in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2015 Jan;13(1):131-7; quiz e7. doi: 10.1016/j.cgh.2014.05.026. Epub 2014 Jun 30.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMV infection
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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