Epilepsy
Conditions
Keywords
Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy
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. .
Interventions
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactFaming Zhang, MD,PhD
Outcome results
None listed