Fecal Microbiota Transplantation for Epilepsy
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|ClinicalTrials.gov Identifier: NCT02889627|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Fecal microbiota suspension||Phase 2 Phase 3|
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.Patients were required to stop antiepileptic drugs after FMT and the follow up last for 3 months.The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: FMT with microbiota suspension
Participants undergo repeated FMT with ~50ml microbiota suspension.
Drug: Fecal microbiota suspension
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
Other Name: Washed fecal microbiota
- Frequency of the seizures [ Time Frame: 3months ]The frequency of seizures of patients during the follow-up(3 months) and compare that before FMT.
- gut microbiota analysis [ Time Frame: 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.
- Examination of MRI [ Time Frame: 3months ]Participants were examined by magnetic resonance imaging (MRI) and compared with that before FMT.
- Adverse events [ Time Frame: 3months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889627
|Contact: Faming Zhang, MD,PhDfirstname.lastname@example.org|
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210011|
|Contact: Faming Zhang, MD, PhD 086-25-58509883 email@example.com|
|Principal Investigator:||Faming Zhang, MD,PhD||The Second Hospital of Nanjing Medical University|