Epilepsy Intractable
Conditions
Brief summary
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.
Interventions
DRUGCiprofloxacin Oral Product
The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.
Sponsors
Mazandaran University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Drug-resistant epilepsy with frequency of at least 2 seizure/Week * Acceptance of patients or his/her guardian (Signing informed consent)
Exclusion criteria
* Hypersensitivity to ciprofloxacin or other fluoroquinolones * History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis * Usage of medications with interaction to ciprofloxacin * No reliable contraception * Pregnancy or breastfeeding * Being under treatment with corticosteroid * Usage of antibiotics in recent 2 months or need to use it during the study * Patients who are candidate for epilepsy surgery or other nonmedical treatments * Change in anti-seizure medications (ASMs) during recent month * Patients who will need changes in ASMs dose during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in seizure frequency registered in questionnaire | 4 weeks | Comparison of seizure frequency in 4th week with the frequency at the start of the study. |
| Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit | 7 days | Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study |
| Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR) | 7 days | Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in seizure frequency registered in questionnaire | 12 weeks | Comparison of seizure frequency in 12th week with the frequency at the start of the study |
Countries
Iran
Outcome results
None listed