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Fecal Microbiota Transplantation for Epilepsy

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ClinicalTrials.gov Identifier: NCT02889627
Recruitment Status : Unknown
Verified May 2017 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : September 5, 2016
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE September 5, 2016
Last Update Posted Date April 2, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Frequency of the seizures [ Time Frame: 3months ]
The frequency of seizures of patients during the follow-up(3 months) and compare that before FMT.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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.
Change History Complete list of historical versions of study NCT02889627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Examination of EEG [ Time Frame: 3 months ]
    Participants were examined by electroencephalogram (EEG) and compared with that before FMT.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Epilepsy
Official Title  ICMJE Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Fecal Microbiota suspension
The prepared microbiota suspension was infused into mid-gut.
Study Arms  ICMJE Experimental: FMT with microbiota suspension
Participants undergo repeated FMT with 200ml microbiota suspension.
Intervention: Drug: Fecal Microbiota suspension
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2016)
10
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02889627
Other Study ID Numbers  ICMJE Epilepsy-CN-160816
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Faming Zhang, The Second Hospital of Nanjing Medical University
Study Sponsor  ICMJE The Second Hospital of Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Faming Zhang, MD,PhD Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
PRS Account The Second Hospital of Nanjing Medical University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP