Using fecal microbiota transplantation to treat epilepsy
Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
PHASE2; PHASE3 · The Second Hospital of Nanjing Medical University · NCT02889627
This study is testing whether stool transplants from healthy donors can help people with epilepsy have fewer seizures while they continue their usual medications.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 60 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT02889627 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for epilepsy. Patients diagnosed with epilepsy will receive repeated FMT from healthy donors while maintaining their current antiepileptic medication regimen. The primary outcome measure is the frequency of seizures, while secondary outcomes include the 50% response rate to treatment. The study aims to explore the potential benefits of gut microbiota on neuropsychiatric disorders, particularly epilepsy.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with epilepsy for at least three months who have experienced seizures during the preceding three months.
Not a fit: Patients with severe comorbid conditions or those who have undergone previous fecal microbiota transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce seizure frequency in patients with epilepsy.
How similar studies have performed: While few studies have explored the use of microbiota for brain diseases, this approach is relatively novel and has not been extensively tested in the context of epilepsy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Faming Zhang, MD,PhD — The Second Hospital of Nanjing Medical University
- Study coordinator: Faming Zhang, MD,PhD
- Email: fzhang@njmu.edu.cn
- Phone: 086-25-58509883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis