Fecal Microbiota Transplantation for Epilepsy
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|ClinicalTrials.gov Identifier: NCT02889627|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Fecal Microbiota suspension Drug: Normal saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: FMT with microbiota suspension
Participants undergo single FMT with 200ml microbiota suspension.
Drug: Fecal Microbiota suspension
The prepared microbiota suspension was infused into mid-gut.
Placebo Comparator: FMT with saline
Participants undergo single FMT with 200ml normal saline.
Drug: Normal saline
The saline (placebo) was infused into mid-gut.
- Frequency of the seizures [ Time Frame: 6 months ]The frequency of seizures of patients during the follow-up(6 months) and compare that before FMT.
- Examination of EEG [ Time Frame: 6 months ]Participants were examined by electroencephalogram (EEG) and compared with that before FMT.
- Examination of MRI [ Time Frame: 6 months ]Participants were examined by magnetic resonance imaging (MRI) and compared with that before FMT.
- Adverse events [ Time Frame: 6 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889627
|Contact: Faming Zhang, MD,PhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Faming Zhang, MD,PhD||Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|