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Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03467841
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : March 19, 2018
Assiut University
Information provided by (Responsible Party):
Dr mohammedRmadan hamad, Assiut University

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.

Condition or disease Intervention/treatment
Cmv Colitis Device: CMV IgM, IgG in blood real time PCR for serum CMV DNA .

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).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Intervention Details:
  • Device: CMV IgM, IgG in blood real time PCR for serum CMV DNA .
    Colonoscopic examination will be done for all studied patients after standardbowel preparation using a Pentax videoscope to= Assess the endoscopic lesions using Mayo endoscopic subscore

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
  • CMV IgM, IgG in blood
  • real time PCR for serum CMV DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study will be consecutively included 50 adult patients with moderate to severe ulcerative colitis not responding to conventional therapy. These patients will be evaluated for the presence of CMV infection.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03467841

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Contact: mohammed hamad 01147647663
Contact: Dr Elham hassan 01002963415

Sponsors and Collaborators
Dr mohammedRmadan hamad
Assiut University

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Responsible Party: Dr mohammedRmadan hamad, Tropical Medicine and Gastroenterology department Faculty of Medicine Assiut University, Assiut University Identifier: NCT03467841     History of Changes
Other Study ID Numbers: CMV infection
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases