Epilepsy
Conditions
Interventions
Treatment group 1:Pefikan + complex dietary fiber RGFX
Treatment group 2:Peifican + placebo 2
Treatment group 3:Compound dietary fiber RGFX+ placebo 1
Placebo control group:Placebo 1 + placebo 2
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.All patients meet the diagnostic criteria of the International Anti-Epilepsy Federation (ILAE), that is, only one seizure can be diagnosed as epilepsy, but the seizure can be diagnosed only if any of the following conditions are met; (1)At least 2 non-induced or non-reflex seizures with a time interval > 24h; (2)A single non-induced or non-reflexes seizure, and the risk of recurrence in the next 10 years is equivalent to the risk of recurrence after two non-induced seizures, at least greater than 60%; (3)Diagnosis of a certain epileptic syndrome, as for the selection of more than 60%, because it is the lower limit of the confidence interval for the risk of recurrence of two non-induced seizures). 2.Meet ILAE's diagnosis of refractory epilepsy, that is, the use of correctly selected and tolerated two antiepileptic drugs (monotherapy or combination), and still failed to achieve sustained seizure-free; 3.Patients had at least one seizure in each of the three consecutive 4-week baseline observations; 4.Aged 16 to 50 years; 5.MMSE scale score > 23; 6.The patient agrees to the treatment in this study and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe digestive, cardiovascular, respiratory, liver, urinary system or genetic metabolic diseases, or congenital immune deficiency; 2.Severe vomiting, fever or infectious disease activity; 3.Patients who have received transplantation operation, stem cell therapy, allogeneic blood product infusion within half a year, and patients with hemolytic disease; 4.Chronic gastrointestinal diseases; 5.Celiac disease; 6.Seizures related to alcohol or substance overuse, pregnancy and/or breastfeeding; 7.Status epilepticus in the past 12 months; 8.Ongoing ketogenic therapy; 9.Severe liver or renal insufficiency; 10.Lactose intolerance; 11.Severe mental illness; 12.The patient had taken antibiotics, gastrointestinal motility drugs, probiotics and dietary fiber within 1 month.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Quality of life in patients with epilepsy;sleep quality;evaluation of anxiety;evaluation of depression;evaluation of cognitive function;evaluation of cognitive function;evaluation of constipation;brain function evaluation;Abnormal discharge;Behavioral indicators of saccade;gut flora;Neuroimmune indicators; | — |
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency; | — |
Countries
China
Contacts
Public ContactChen Lei
West China Hospital of Sichuan University
Outcome results
None listed