跳至主要内容
临床试验/NCT04668014
NCT04668014已完成不适用

The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月1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
Mayo Clinic
入组人数
20
试验地点
1
主要终点
Presence of C. difficile within the sigmoid colonic mucosal tissue

研究概览

简要总结

This research is being done to study the ability of C. difficile to colonize the colonic mucosa of individuals with no prior history of C. difficile infection.

详细描述

The ability of C. difficile to colonize the mucosa of the colon will be studied in healthy individuals with no history of C. difficile infection who are undergoing colonoscopy for colon cancer/polyp screening purposes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 and over
  • No history of C. difficile infection
  • Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms.

排除标准

  • Known active pregnancy
  • Other known active gastrointestinal infectious process
  • Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease)
  • Vulnerable adults
  • Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes

结局指标

主要结局

Presence of C. difficile within the sigmoid colonic mucosal tissue

时间窗: 1 day (At time of biopsy)

C. difficile identified on fluorescence microscopy via FISH staining

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Purna C. Kashyap, MBBS

Principal Investigator

Mayo Clinic

研究点 (1)

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