Clinical trial
Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
Name
Epilepsy-CN-160816
Description
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.
Trial arms
Trial start
2016-11-01
Estimated PCD
2025-10-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Fecal microbiota suspension
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
Arms:
FMT with microbiota suspension
Other names:
Washed fecal microbiota
Size
50
Primary endpoint
Frequency of the seizures
3months
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-20
1 organization