Cmv Colitis Clinical Trial
Official title:
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05522283 -
Stool and Serum CMV-PCR in Diagnosing CMV Colitis
|