NCT05160350已完成4 期
Investigation of Probiotic Effect on Seizure Frequency of Adult Patients With Drug-resistant Epilepsy; A Randomized Double-blind Parallel Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in seizure frequency
研究概览
简要总结
This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug resistant epilepsy
排除标准
- •Hypersensitivity to probiotic
- •Acute pancreatitis
- •Pregnancy
- •Breastfeeding
- •Being under treatment with corticosteroids
- •Being under treatment with antibiotics during 2 months before enrollment
- •Need for antibiotic therapy during the study
- •Change in anti-seizure medication within the month before enrollment
研究组 & 干预措施
Probiotic
Active Comparator
Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day
干预措施: Probiotic (Drug)
Placebo
Placebo Comparator
Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day
干预措施: Probiotic (Drug)
结局指标
主要结局
Change in seizure frequency
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Nasim Tabrizi
Associate professor of neurology
Mazandaran University of Medical Sciences
研究点 (1)
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