Epilepsy
Conditions
Interventions
Treatment group 2:Probiotics + placebo 2 (simulated prebiotics)
Control group:Placebo 1 (simulated probiotics) + placebo 2 (simulated prebiotics)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. All patients met the diagnostic criteria for epilepsy (2014 edition) and refractory epilepsy (2010 edition) of the International Federation against Epilepsy (ILAE); 2. At least one seizure per month; 3. Aged 18-50 years; 4. The patient agreed to the treatment in this study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with heart disease (severe arrhythmia, QTc > 450ms), severe malignant tumor or genetic metabolic disease, and congenital immune deficiency; 2. Severe liver or renal insufficiency (transaminase exceeding 3 times the upper limit of normal value, total bilirubin and creatinine exceeding 1.5 times the upper limit of normal value, or creatinine clearance 500ml/ week) or substance abuse, pregnancy, and/or breastfeeding; 8. Persistent epilepsy within the past 12 months; 9. Adjusting antiepileptic drugs within a month; 10. Undergoing ketogenic treatment or surgical treatment for epilepsy within six months; 11. Use glucocorticoid and other immunosuppressants or regulators; 12. Receive non-inactivated vaccines within one month, such as novel coronavirus and hepatitis B vaccines; 13. Those who have taken probiotic preparations, eaten foods or drinks containing probiotics, probiotics and other intestinal flora regulators or enteral nutrition preparations within the past 1 month; 14. Patients should take antibiotics, gastrointestinal motivity drugs, and proton pump inhibitors within 1 month or for a long time; 15.MMSE scale score < 24 points; 16. Pregnancy, lactation or pregnancy planning within one year; 17. Participating in other interventional clinical trials; 18. The investigator judged that the patient was not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency;Seizure duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure type;Quality of Life in Epilepsy Scale;Pittsburgh Sleep Quality Index;Gleveland Score;Saccade Behavior Index;Intestinal flora;Blood sample index;Hamilton Depression Scale Score;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactChen Lei
West China Hospital, Sichuan University
Outcome results
None listed