Fecal Microbiota Transplantation for Epilepsy

Nanjing Medical University

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Epilepsy

Treatments

Drug: Fecal microbiota suspension

Study type

Interventional

Funder types

Other

Identifiers

NCT02889627

Epilepsy-CN-160816

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

3 to 60 years old

Volunteers

No Healthy Volunteers

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