Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy
研究概览
简要总结
Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE.
The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.
详细描述
This study will be a placebo-controlled, double-blind, and parallel 6-month duration study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 3-18 years with intractable childhood-onset epilepsy.
- •All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
- •The subject is willing and able to comply with the study requirements
排除标准
- •Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR < 60 mL/min/1.73 m2 or electrolyte imbalance.
- •Patients who are currently using or used antibiotics therapy in the preceding month
- •Patients who are currently using or used other probiotic products in the preceding two weeks
- •Patients scheduled to undergo GIT surgery or those who underwent GIT surgery
- •Patients with a Known allergy to probiotics.
- •Patients receiving artificial enteral or intravenous nutrition
研究组 & 干预措施
Control group
25 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
干预措施: Lactobacillus-Based Capsule (Drug)
Probiotic Group
25 patients will receive Lactobacillus species 5 billion colony forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.
干预措施: Lactobacillus-Based Capsule (Drug)
结局指标
主要结局
effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy
时间窗: 6 months
effectivness can be defined as more than 50% reduction in number of seizures.
次要结局
- 1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab)(6 months)
研究者
Amira Roshdy
Assistant Lecturer of Clinical Pharmacy
Tanta University