Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frequency of the seizures
研究概览
简要总结
Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation for epilepsy.
详细描述
Very few literatures reported the clinical use of microbiota or bacteria for brain diseases. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (FMT). This study aims to evaluate the efficacy and safety of FMT for epilepsy. Patients were diagnosed as epilepsy by electroencephalogram (EEG) and MRI and clinical data when the study began and thent received repeated FMT with fecal from healthy donors.The antiepileptic medication regimen of patients remained unchanged after FMT. The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate.
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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
- 3 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;
排除标准
- •had other severe diseases, including other intestinal disorders (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous FMT or WMT, had taken antibiotics within three months before starting WMT
研究组 & 干预措施
FMT with microbiota suspension
Participants undergo repeated FMT with ~50ml microbiota suspension.
干预措施: Fecal microbiota suspension (Drug)
结局指标
主要结局
Frequency of the seizures
时间窗: 3months
the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT
次要结局
- gut microbiota analysis(baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT)
- Adverse events(3months)
研究者
Faming Zhang
Associate professor, Gastroenterology
The Second Hospital of Nanjing Medical University