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临床试验/NCT05183256
NCT05183256已完成不适用

Development of the Cohort of the Patients With Inflammatory Bowel Disease in Yeouido St. Mary's Hospital

Yeouido St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Number of participants with the remission of disease activity.

研究概览

简要总结

Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The aim of this study is to analyze gut microbiota in IBD patients.

详细描述

Inflammatory bowel disease (IBD) (Crohn's disease (CD) and ulcerative colitis (UC)) occurs worldwide with differences in epidemiology, etiology, and phenotype between regions. Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The DNA of microbiota will be investigated with samples of stool, colon tissue. The aim is to establish a cohort group for IBD (1), to make a database on cohort group characteristics such as endoscopic findings, disease severity, epidemiology, and prognosis (2), to analyze gut flora in IBD patients (3).

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
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The below 3 conditions must be met simultaneously.
  • Patient who can voluntarily consent to this study.
  • Patient who has inflammatory bowel disease.
  • Patient who is aged less than 75 years.

排除标准

  • a patient meets any of the below conditions.
  • If a patient has an IBD other than UC and CD.
  • If a patient is vulnerable due to his/her position as an employee of Yeouido St.Mary's hospital or a medical student of the Catholic University of Korea.
  • If a patient is pregnant.
  • Foreign personal who cannot speak Korean.

结局指标

主要结局

Number of participants with the remission of disease activity.

时间窗: through study completion, an average of 2 year

Disease activity is assessed in a clinical, endoscopic, and biochemical way. Each activity is determined by the Mayo score (in UC), Crohn's Disease Activity Index (in CD), Ulcerative Colitis Endoscopic Index of Severity (in UC), Simple Endoscopic Score for Crohn Disease (in CD), and biochemical findings (e.g. fecal calprotectin).

次要结局

未报告次要终点

研究者

发起方
Yeouido St. Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilsoo Kim, MD

Principal Investigator

Yeouido St. Mary's Hospital

研究点 (1)

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