Fecal Microbiota Transplantation for Epilepsy

Study Overview
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Brief Summary
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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
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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. .

Official Title
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Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Fecal microbiota suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: epilepsy diagnosed by typical electroencephalogram (EEG) and Magnetic resonance imaging (MRI) frequent relapses of epilepsy (> one seizure per 6 months) at a stabilize extent every year Exclusion Criteria: complicated with certain brain disease, including tumor,injury,cerebrovascular disease complicated with other severe disease, including cancers, organ failure, heart diseases Follow-up less than 6 months

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT with microbiota suspension<br>Participants undergo repeated FMT with  50ml microbiota suspension. | Drug: Fecal microbiota suspension<br>* The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.<br>* Other names: Washed fecal microbiota;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the seizures | the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota analysis | 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. | baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT | 
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT. | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy