跳至主要内容
临床试验/NCT05714566
NCT05714566招募中不适用

Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
C.difficile positive

研究概览

简要总结

The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.

type of study: observational study participant population/health conditions

  1. population diagnosed with Ulcerative colitis or Crohn's disease
  2. Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.

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

  • inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
  • age from 18 to 75 years old

排除标准

  • other infection caused diarrhea
  • other metabolic diseases or inflammatory diseases
  • patients who are not able to send back samples 4-6 weeks after therapy

结局指标

主要结局

C.difficile positive

时间窗: 1 day

C.difficile toxin test is positive

C.difficile negative

时间窗: 1 day

C.difficile toxin test is negative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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