A Randomised Double-blind Placebo-Controlled Trial of Multi-Strain Probiotic Supplementation (Hexbio®) in Malaysian Patients With Drug-Resistant Epilepsy (ProbE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
Probiotics are good, live bacteria and/or yeast, that live in our guts and causes no harm. They help in digestion and overall well-being of our gut system. The purpose of the study is to assess the effect of probiotics on the quality of life and seizure frequency in epilepsy patients with uncontrolled seizures.
This experimental study involves an interview by the researchers from UKM for the demographic of epilepsy, seizure control and quality of life using a questionnaire. The questionnaire will take about 15 minutes to complete, and you will need to answer all questions without assistance.
You will be randomized either into the active group or the placebo group. If you are in the active group, you will need to take one HEXBIO MCP Granule probiotics sachet directly before meal (drink water if needed) twice daily, for two months, in addition to your pre-existing epilepsy treatment. The HEXBIO MCP Granule probiotic consists of the following probiotics: Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium infantis and Bifidobacterium longum. Initially, some people may experience temporary mild gastrointestinal symptoms such as abdominal cramping, soft stools and flatulence as body adapts to the introduction of friendly bacteria. The symptoms will subside gradually after few days.
If you are in the placebo group, you will also need to take one sachet twice daily before meal, for two months, in addition to the epilepsy treatment. The placebo sachets will contain the same ingredient as the probiotic sachet but without the Lactobacillus sp. and Bifidobacterium sp. The placebo sachet is also to be taken the same way as the probiotic sachet.
At two months of follow up, you will be interviewed once again to assess the changes of seizure frequency (using seizure diary), quality of life and the adverse effects of experienced. A sachet-count (using sachet diary) will also be done to assess the compliance.
Benefits This study is done in an attempt to assess the changes in quality of life and seizure frequency in patients with refractory epilepsy as compared to the control group.
Risks There is no risk in this study. All information disclosed during this study is strictly confidential. You do not have to pay to participate in this study.
If seizure or quality of life worsened during this period, you will be referred to the respective team for the optimization of anti-seizure medications.
Do you have to take part? Participation in this study is voluntary. If you agree to take part, then you will be asked to sign the "informed Consent Form". Should you decide to participate, you can still withdraw at any time during the study without penalty. Your data will be discarded and not be used. Regardless of your decision at any point in time, your treatment will not be affected.
Data and Confidentiality The data in this study will be made into a report which may be published. The data will be reported in a collective manner with no reference to an individual. Hence your identity will be kept confidential. There is no conflict of interest among the researchers.
详细描述
Epilepsy is a chronic neurological disorder, characterized by two or more unprovoked seizures occurring more than 24 hours apart owing to excessive or asynchronous brain neuronal activities. It has a high global prevalence whereby the overall lifetime prevalence is 7.6 per 1,000 populations worldwide.1 Similarly, in Malaysia, the prevalence of epilepsy is up to 7.8 in 1,000 populations. 2
The mainstay of treatment for all types of epilepsy is anti-seizure medications (ASM). There are many types of ASM that are being used currently, ranging from a narrow to a broad spectrum. In spite of this, only 70% of patients on single ASM are able to achieve seizure-free. The remaining one third will need an addition or substitution of ASM.2
Refractory epilepsy is defined as persistent seizures despite being on optimal dose of two or more ASM. The standard treatment for refractory epilepsy includes ASM polytherapy and non -pharmacological methods. The choice of ASM includes medications such as phenytoin, valproate, carbamazepine, topiramate, levetiracetam, lacosamide, lamotrigine, oxcarbazepine, clonazepam, eslicarbazepine, zonisamide and perampanel. Ketogenic diet, surgery, and neurostimulator implantation were the non-pharmacological alternatives employed on these patients but only showed minimal effectiveness.3 If left untreated, it is associated with a poor quality of life (QoL), higher mortality rate, and increased socio-economic burden.
In recent years, the interest in probiotics was at all-time high in Western countries and China. The bidirectional relationship between the gut microbiota and brain, also known as the 'microbiota-gut-brain axis' has gained the attention of many, especially in those related to Parkinson's disease, autism spectrum disorders (ASD), schizophrenia, and multiple sclerosis. Probiotics improved non-motor symptoms in Parkinson's Disease. 4Probiotics as an adjunctive were also proven to prevent the somatic symptoms in schizophrenia and improve autistic symptoms in autism spectrum disorder. 5-7
Probiotics had been used in preclinical and clinical research contexts and shown positive effects on early life stress-induced anxiety and depression-related behavior in rodents, however specific mechanism remains unknown.8,9The 'microbiota-gut-brain axis' is a complex interaction involving the neuroendocrine, immunological and direct neural mechanisms. It is hypothesized that microbes and their metabolites alter the transport of neuroactive chemicals into the nervous system thus increasing the permeability of the gut wall and allowing the psychoactive chemicals to enter the blood and subsequently to the brain. 10-13
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Inclusion Criteria(s)
- •Patients diagnosed with refractory focal epilepsy
- •Have at least one self-reported seizure per month
- •On two or more ASM
- •Aged 18 years and above, who is able to read and write in English and/or Bahasa Malaysia
- •Provide informed consent
排除标准
- •Had status epilepticus in the last 12 months
- •Changes in ASM dose or type in the 30 days prior to inclusion to this study
- •Seizures related to alcohol / drug abuse / metabolic cause / infections.
- •Use of probiotics, immune-suppressants, prolonged antibiotics (more than 2 weeks), traditional treatment, supplements in the 30 days before the inclusion of the study.
- •Gastrointestinal related diseases such as lactose intolerance, coeliac disease
- •Renal or hepatic insufficiency (Based on recent six-month blood profile)
- •Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)
结局指标
主要结局
Quality of Life
时间窗: 2 months
To compare the quality of life score pre- and post-administration of probiotics inter- and intragroup of refractory epilepsy patients
次要结局
- Seizure Frequency(2 months)