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临床试验/NCT03698500
NCT03698500Unknown不适用

Blood Level of Specific microRNA Pattern as Potential Biomarker for Inflammatory Bowel Disease

University Hospital Muenster2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2017年1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
350
试验地点
2
主要终点
Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC

研究概览

简要总结

The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn's disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Furthermore, the accuracy of miRNA-320a to distinguish CD or UC from irritable bowel syndrome (IBS) should be evaluated .

The study is designed as a single center non-randomised prospective trial.

详细描述

Inflammatory bowel disease (IBD), which comprises Crohn's disease (CD) and ulcerative colitis (UC), is a chronic-remittent disease of the gastrointestinal tract with leading symptoms such as diarrhea, abdominal pain and rectal bleeding. Absence of mucosal inflammation (so called mucosal healing) is a promising treatment target.as it leads to reduction of colectomy rates, hospitalization and need for surgery. However, overtreatment with severe combined immunosuppressive therapy always bears the risk of severe side-effects such as opportunistic infections. To assess the course of disease, clinical evaluation, noninvasive diagnostic or imaging and invasive endoscopic techniques are currently used. As frequent endoscopical monitoring is not always possible, more specific and noninvasive biomarker are needed to monitor disease activity. The commonly used noninvasive biomarkers C-reactive protein and fecal Calprotectin, which are useful to detect disease activity, are limited due to the lacking specificity for IBD and the weak correlation with the extend of disease. Overall the currently available tools to noninvasively follow the course of disease activity do not possess appropriate specificity, sensitivity and cost effectiveness for in- and outpatient clinical monitoring.

Recently, we could demonstrate the potential of miR(microRNA)-320a to monitor disease activity in experimental colitis mouse models.

The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with inflammatory bowel disease as compared to healthy controls, non IBD-colitis and IBS.

The study is planned as a prospective single center study.

Number of patients: 7 groups of 50 patients

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients with Crohn's disease or ulcerative colitis
  • Control patients: healthy patients or patients with colitis of other origin than Crohn's disease or ulcerative colitis as well as patients with IBS

排除标准

  • Age under 18 years
  • Pregnancy
  • Inability to understand information for participation
  • Refusal of participation

结局指标

主要结局

Correlation between microRNA expression level in peripheral blood (qPCR) and disease activity of intestinal Inflammation of CD and UC

时间窗: 1 day

次要结局

  • Assessment of the potential of specific miRNAs to discriminate CD and UC in peripheral blood (qPCR)(1 day)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (2)

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