epilepsy
Conditions
Interventions
Control group:Placebo (Maltodextrin)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2-70 years, no gender limit; 2. Uncontrolled seizures in the presence of at least one antiepileptic drug; 3. At least 1 seizures every 4 weeks during the first 8 weeks of enrollment; 4. All antiepileptic drugs or interventions must be stable for at least 4 weeks prior to enrollment and are expected to remain stable throughout the trial; 5. Patients should have at least 1 seizures during the baseline period (4 weeks)
Exclusion criteria
Exclusion criteria: 1. Other probiotics or antibiotics within 1 month prior to screening; 2. Patients with intracranial space-occupying lesions, malformations, or other lesions that may be surgically removed; 3. Studies and assessments of the impact of other diseases; 4. Severe cardiac, liver and renal dysfunction; 5. Failure to complete regular follow-up and observation; 6. Participating in other clinical trials; 7. Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in seizure frequency (normalized to 28-day rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients without seizures;Seizures were reduced by 50% and 90% in patients;Liverpool epileptic seizure severity scale;Assessment of quality of life in epileptic patients;Beck depression inventory (BDI);Beck anxiety inventory;Pittsburgh sleep quality index;Montreal cognitive assessment scale;Assessment of gastrointestinal symptoms; | — |
Countries
China
Contacts
Public ContactHong Zhen
West China Hospital, Sichuan University
Outcome results
None listed