NCT02889627

Fecal Microbiota Transplantation for Epilepsy

Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 60 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Fecal microbiota suspension	The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.

Timeline

• Start date: 2016-11-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2016-09-05
• Last updated: 2024-03-20

Locations

1 site across 1 country: China