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.
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||Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University|