Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with refractory, recurrent or relapsing C. difficile infection (RCDI), as defined in guidelines as a relapse of CDI after having at least 3 episodes of mild to moderate CDI and failure of a 6- to 8-week taper with vancomycin with or without an alternative antibiotic or at least 2 episodes of severe CDI resulting in hospitalization and associated with significant morbidity;
- •Willingness to accept risk of healthy unrelated donor stool.
排除标准
- •Delayed gastric emptying syndrome;
- •Known chronic aspiration;
- •Swallowing dysfunction or oral-motor dyscoordination;
- •Pregnant or breast-feeding women;
- •Usage of probiotics, prebiotics or synbiotics within the last month;
- •Smoking or alcohol use within the last month;
- •Patients with an exacerbation of condition not because of CDI;
- •Patients on major immunosuppressive agents or with any other cause of severe immunodeficiency;
- •Patients with a history of significant allergy because of diet;
- •Patients on any agents affecting fecal bacteriology because of comorbidities.
研究组 & 干预措施
Capsulized freeze-dried FMT
Reconstitution of normal flora with capsulized freeze-dried fecal inoculum
干预措施: Fecal Microbiota Transplantation (Drug)
结局指标
主要结局
Efficacy
时间窗: Up to 3 months post-FMT
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
时间窗: Up to 3 months post-FMT
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
次要结局
- Change of fecal bacteriology(Up to 1 month post-FMT)
研究者
Ding Chao
MD candidate
Jinling Hospital, China