Epilepsy. Epilepsy and recurrent seizures
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3-18 years An established diagnosis of drug-resistant epilepsy with two or more seizures during the 7-day baseline period Consent of the patient or the patient's guardian to participate in the study
Exclusion criteria
Exclusion criteria: History of penicillin allergy Patients treated with co-amoxiclav interfering drugs reception of corticosteroids Taking antibiotics in the last 1 month or needing to take another antibiotic during the study period Liver disease Patients who were candidates for epilepsy surgery or other non-pharmacological methods Patients who need to change the dose of anticonvulsant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary laboratory outcome is defined as changes in the microbial load of different species in stool samples on the fifth day compared to baseline. Timepoint: The first stool sample is taken from patients after the initial interview. The second stool sample is taken after 5 days of taking co-amoxiclav, 5-7 days apart from the first sample. Method of measurement: Bacterial copy number is determined in patients' feces samples using real-time PCR technique.;The primary clinical outcome is response rate at week 12. A response rate of =50% reduction in seizures is classified as "responder" and less than 50% reduction in seizure frequency is classified as "non-responder". Timepoint: The patient and his/her family are asked to record the frequency of seizures up to 12 weeks after receiving the drug. Method of measurement: Self report. | — |
Countries
Iran (Islamic Republic of)
Contacts
Mazandaran University of Medical Sciences