Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in seizure frequency registered in questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug-resistant epilepsy with frequency of at least 2 seizure/Week
- •Acceptance of patients or his/her guardian (Signing informed consent)
排除标准
- •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
研究组 & 干预措施
Ciprofloxacin
干预措施: Ciprofloxacin Oral Product (Drug)
结局指标
主要结局
Changes in seizure frequency registered in questionnaire
时间窗: 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
时间窗: 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)
时间窗: 7 days
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
次要结局
- Changes in seizure frequency registered in questionnaire(12 weeks)
研究者
Nasim Tabrizi
Associate professor of neurology
Mazandaran University of Medical Sciences