epilepsy
Conditions
Interventions
Treatment group 2: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; 3. Patients who have received transplant surgery, stem cell therapy, transfusion of allogeneic blood products within six months, hemolytic diseases, and inability to eat normally; 4. Moderate to severe chronic abdominal and gastrointestinal diseases; 5. Severe vomiting, fever, chronic bacterial infection or hepatitis B, hepatitis C, HIV and other viral infectious diseases; 6. Severe mental illness; 7. Seizures related to alcohol (> 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. Patients judged by the investigator to be unfit for clinical trials; 19. Presence of metals in the body or other contraindications for magnetic tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI;Diffusion tensor imaging;Seizure frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;Quality of life scale for people with epilepsy;Gleveland score;Intestinal flora;Blood sample index;Hamilton depression scale;Hamilton anxiety scale;Seizure severity scale; | — |
Countries
China
Contacts
Public ContactChen Lei
Outcome results
None listed