Fecal Microbiota Transplantation for Epilepsy
- Registration Number
- NCT02889627
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
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.
- Detailed Description
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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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT with microbiota suspension Fecal microbiota suspension Participants undergo repeated FMT with \~50ml microbiota suspension.
- Primary Outcome Measures
Name Time Method Frequency of the seizures 3months the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT
- Secondary Outcome Measures
Name Time Method gut microbiota analysis baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT The stool samples of participants before and after FMT were collected and analized, by 16S rRNA and were used to investigate the crucial microbiota for devising a more efficient treatment strategy for epilepsy.
Adverse events 3months Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.
Trial Locations
- Locations (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China