Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)
研究概览
简要总结
The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient Inclusion Criteria
- •Older than 18 months of age
- •FMT procedure has been decided by the treating gastroenterologist and was based on:
- •Recurrent or relapsing CDI and:
- •Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for <18years and insurance authorization may not be possible).
- •At least 2 episodes of CDI requiring hospitalization
- •Moderate CDI not responding to vancomycin for at least a week.
- •Severe CDI with no response to vancomycin after 4 hours.
- •English speaking
排除标准
- •Lack of informed consent/assent.
- •Not eligible for FMT procedure
研究组 & 干预措施
Pediatrics, C. Diff.
Fecal Microbiota Transplantation in children with c. difficile infection
干预措施: Fecal microbiota (Other)
结局指标
主要结局
Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)
时间窗: 3 years
次要结局
未报告次要终点
研究者
Steve Werlin
MD, Professor, Principal Investigator
Medical College of Wisconsin