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Trial record 1 of 1 for:    microbiota transplant epilepsy | Recruiting Studies
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Fecal Microbiota Transplantation for Epilepsy

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Faming Zhang, The Second Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT02889627
First received: August 16, 2016
Last updated: May 24, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Epilepsy Drug: Fecal Microbiota suspension Drug: Normal saline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy

Resource links provided by NLM:


Further study details as provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: June 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 then were randomly assigned to groups that received single FMT with fecal from healthy donors or placebo with equal water. Patients (blinded) were required to stop antiepileptic drugs after FMT and the follow up last for 6 months.The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the examination of EEG and MRI.
  Eligibility

Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02889627

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

Locations
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
Principal Investigator: Faming Zhang, MD,PhD Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
  More Information

Publications:
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02889627     History of Changes
Other Study ID Numbers: Epilepsy-CN-160816
Study First Received: August 16, 2016
Last Updated: May 24, 2017

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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 27, 2017