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临床试验/NCT03467841
NCT03467841Unknown不适用

Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis

Dr mohammedRmadan hamad0 个研究点目标入组 50 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Cytomegalovirus infection in steroid-refractory ulcerative colitis

研究概览

简要总结

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.

详细描述

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) .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Cytomegalovirus infection in steroid-refractory ulcerative colitis

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Dr mohammedRmadan hamad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr mohammedRmadan hamad

Tropical Medicine and Gastroenterology department Faculty of Medicine Assiut University

Assiut University

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