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Fecal Microbiota Transplantation for Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota suspension
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT with microbiota suspension

Arm Description

Participants undergo repeated FMT with ~50ml microbiota suspension.

Outcomes

Primary Outcome Measures

Frequency of the seizures
the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT

Secondary Outcome Measures

gut microbiota analysis
The stool samples of participants before and after FMT were collected and analized, by 16S rRNA and were used to investigate the crucial microbiota for devising a more efficient treatment strategy for epilepsy.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.

Full Information

First Posted
August 16, 2016
Last Updated
August 28, 2023
Sponsor
The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02889627
Brief Title
Fecal Microbiota Transplantation for Epilepsy
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.The antiepileptic medication regimen of patients remained unchanged after FMT. The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT with microbiota suspension
Arm Type
Experimental
Arm Description
Participants undergo repeated FMT with ~50ml microbiota suspension.
Intervention Type
Drug
Intervention Name(s)
Fecal microbiota suspension
Other Intervention Name(s)
Washed fecal microbiota
Intervention Description
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
Primary Outcome Measure Information:
Title
Frequency of the seizures
Description
the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT
Time Frame
3months
Secondary Outcome Measure Information:
Title
gut microbiota analysis
Description
The stool samples of participants before and after FMT were collected and analized, by 16S rRNA and were used to investigate the crucial microbiota for devising a more efficient treatment strategy for epilepsy.
Time Frame
baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD,PhD
Organizational Affiliation
The Second Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24315484
Citation
Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.
Results Reference
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PubMed Identifier
22183182
Citation
Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.
Results Reference
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PubMed Identifier
26939622
Citation
Cui B, Li P, Xu L, Peng Z, Xiang J, He Z, Zhang T, Ji G, Nie Y, Wu K, Fan D, Zhang F. Step-up fecal microbiota transplantation (FMT) strategy. Gut Microbes. 2016 Jul 3;7(4):323-328. doi: 10.1080/19490976.2016.1151608. Epub 2016 Mar 3. Erratum In: doi: 10.1186/s12967-015-0646-2.
Results Reference
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Fecal Microbiota Transplantation for Epilepsy

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