Fecal Microbiota Transplantation for Epilepsy
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ClinicalTrials.gov Identifier: NCT02889627 |
Recruitment Status :
Recruiting
First Posted : September 5, 2016
Last Update Posted : January 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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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.
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Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy |
Actual Study Start Date : | June 2016 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: FMT with microbiota suspension
Participants undergo repeated FMT with ~50ml microbiota suspension.
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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.
- Adverse events [ Time Frame: 3months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.

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Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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,PhD | 086-25-58509883 | fzhang@njmu.edu.cn |
China, Jiangsu | |
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 fzhang@njmu.edu.cn |
Principal Investigator: | Faming Zhang, MD,PhD | The Second Hospital of Nanjing Medical University |
Responsible Party: | Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT02889627 |
Other Study ID Numbers: |
Epilepsy-CN-160816 |
First Posted: | September 5, 2016 Key Record Dates |
Last Update Posted: | January 31, 2022 |
Last Verified: | January 2022 |
Fecal Microbiota Transplantation Gut microbiota Brain-gut axis Epilepsy |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |