NCT05703477已完成不适用
The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1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
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes of microbiota before and after FMT treatment
研究概览
简要总结
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 18 years old;
- •positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
- •can tolerate nasojejunal tube and complete full course of FMT treatment;
- •the clinical data are relatively complete and there is follow-up available for evaluation
排除标准
- •accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
- •associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
结局指标
主要结局
changes of microbiota before and after FMT treatment
时间窗: 7 days, 1 month
次要结局
未报告次要终点
研究者
Huanlong Qin
Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Shanghai 10th People's Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel DiseaseFecal Microbiota TransplantationNCT04436874First Affiliated Hospital of Kunming Medical University240
终止
1 期
Fecal Transplantation for Inflammatory Bowel DiseaseInflammatory Bowel DiseaseNCT02391012Meir Medical Center9
已完成
不适用
Fecal Microbiota Transplantation in Patients With Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS)NCT02092402Örebro University, Sweden17
已完成
2 期
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile InfectionClostridia Difficile ColitisClostridium Difficile DiarrheaNCT03806803University of Alberta138
暂停
不适用
Fecal Microbiota Transplantation for Patients With Chronic Widespread PainChronic Widespread PainNCT05700331Chinese University of Hong Kong20