The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Mucosal presence
研究概览
简要总结
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.
详细描述
Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mucosal presence
时间窗: 1-14 days post C. Difficile treatment
Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples
Disease recurrence
时间窗: 8 weeks
Determination of recurrent C. difficile infection based on symptoms and potential clinical testing
次要结局
未报告次要终点
研究者
Purna C. Kashyap, MBBS
Principal Investigator
Mayo Clinic