The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy
研究概览
简要总结
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic.
详细描述
Epilepsy is a neurological disease with a prevalence of 0.6%. Despite the high number of antiepileptic drugs available, 20-30% of patients fail to control their seizures even with a correct treatment, this is known as drug-resistant epilepsy. This type of epilepsy limits severely the quality of life in patients and increases their morbidity and mortality.
There are different therapeutic strategies for the treatment of drug-resistant epilepsy such as the vagus nerve stimulation, which has an effectiveness of approximately 50% reduction of seizures in 50% of patients. Another one is epilepsy surgery, which can achieve up to 70% of crisis control with specifically selected surgery for certain patients. On the other hand, the ketogenic diet has nearly 30% effectiveness, which is defined as a seizure reduction of more than 50%. Despite all these treatments, there is still a group of patients that keeps showing epileptic seizures.
The microbiota is a collective of microorganisms that live in a symbiotic relationship within our organism. Currently, it is known that there is a bidirectional relationship between microbiota-gut-brain. Probiotics are live microorganisms that can benefit the health of the host when administered in adequate doses.
The purpose of the study is to prove the quality of life improvement in drug-resistant patients after the administration of a probiotic for 4 months in order to reduce the number of seizures. Additionally, the parameters of inflammatory cytokines will be evaluated as well as the probiotic medication safety will be assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years-old.
- •Diagnosis of drug-resistant epileptic seizures.
- •Under stable treatment with antiepileptic drugs for at least 30 days before their inclusion.
- •Occurrence of at least one seizure per month.
- •Acceptance and informed consent for the inclusion of the patient in the study protocol.
排除标准
- •Stable epilepsy.
- •Idiopathic generalized epilepsy.
- •Epileptic status in the previous 12 months.
- •Change in the dose or type of antiepileptic drug within 30 days prior to the start of the study.
- •Active consumption of alcohol or substances of abuse.
- •Pregnancy and / or mothers during lactation period.
- •Patients treated with probiotics from 30 days before the start of the study.
- •Chronic gastrointestinal problems (for example irritable bowel).
- •Liver or kidney problems.
- •Lactose intolerant or celiac.
- •Immunosuppressed.
- •Patients on chronic antibiotic treatment.
- •Impossibility to fill in a questionnaire, by the patient or the person responsible, and to follow the schedule of visits.
- •Progressive neurological deterioration (tumors or metastasis of the central nervous system (CNS), Alzheimer's disease, vascular dementias).
- •Use of antiepileptic drugs in research.
- •Patients with an expectation of life <1 year.
研究组 & 干预措施
Probiotic
Probiotic administration
干预措施: Probiotic (Other)
结局指标
主要结局
effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy
时间窗: From visit 2 to visit 3 (administration of probiotics, 4 months)
effectiveness can be defined as the reduction in number of seizures of at least 50%
次要结局
- Quality of life(From visit 2 to visit 3 (administration of probiotics, 4 months))
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).(From visit 2 to visit 3 (administration of probiotics, 4 months))
- Assessing the anti-inflammatory effect of probiotics(From visit 2 to visit 3 (administration of probiotics, 4 months))
研究者
María Gómez Eguílaz
principal investigator
Fundación RiojaSalud