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
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
- population diagnosed with Ulcerative colitis or Crohn's disease
- 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
- 否
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
研究点 (1)
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