Fecal Microbiota Transplantation for Epilepsy

Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Fecal microbiota suspension

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.

.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Faming Zhang, MD,PHD; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Faming Zhang, MD, PhD; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;

Exclusion Criteria:

had other severe diseases, including other intestinal disorders (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous FMT or WMT, had taken antibiotics within three months before starting WMT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Washed fecal microbiota

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of the seizures	the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT	3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.	3months
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.	baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Faming Zhang, MD,PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimated): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; Fecal Microbiota Transplantation; Gut microbiota; Brain-gut axis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Epilepsy-CN-160816