The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Disease recurrence
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 diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of disease.
详细描述
Patients who were recently diagnosed with C. difficile infection will undergo assessment of both before treatment and after completing treatment to study the presence of C. difficile in the colonic mucosa pre as well as assessment for microbiome and patient/clinical factors that may contribute to disease recurrence. Assessment will include sigmoid colon biopsies, blood draw, stool samples and surveys.
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
- •Adults aged 18 and over
- •Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea
排除标准
- •Known active pregnancy
- •Prior diagnosis of C. difficile infection within 2 months of this diagnosis
- •Other known active gastrointestinal infectious process
- •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
Disease recurrence
时间窗: 8 weeks post treatment of C.difficile infection
Based on clinical stool testing and symptoms
次要结局
- Change in mucosal presence of C. difficile(Baseline, approximately 1-14 days post treatment of C. difficile infection)
研究者
Purna C. Kashyap, MBBS
Principal Investigator
Mayo Clinic