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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
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Fecal microbiota suspension Phase 2 Phase 3

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of the seizures [ Time Frame: 3months ]
    The frequency of seizures of patients during the follow-up(3 months) and compare that before FMT.


Secondary Outcome Measures :
  1. 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.

  2. Adverse events [ Time Frame: 3months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn

Locations
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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   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Faming Zhang, MD,PhD The Second Hospital of Nanjing Medical University
More Information
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Publications:

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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
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Fecal Microbiota Transplantation
Gut microbiota
Brain-gut axis
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases