Efficacy of Probiotics for Parkinson Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- UPDRS III
研究概览
简要总结
In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
详细描述
The gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and CNS function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (MGBA). Combining the MGBA concept and the theory that Parkinson's disease (PD) is derived in the gut, researchers have studied the relationship between the gut microbiota and the PD neurodegenerative process. Probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting MGBA homeostasis. Lactobacillus plantarum PS128 (PS128) and Lactobacillus paracasei PS23 (PS23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. Furthermore, PS128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the MPTP mouse model of Parkinson's disease. In previous clinical studies, PS128 has been reported to ameliorate motor deficits in PD. PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age between 41-80 years old and at least the elementary education level.
- •Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 3 as rated.
排除标准
- •Diagnosed before 40 years old.
- •Used probiotic products in powder, capsule, or tablet form within four weeks.
- •Have taken antibiotics within four weeks.
- •Those who are not suitable to participate in the research are judged by PI.
结局指标
主要结局
UPDRS III
时间窗: From Baseline to 12 Weeks Assessed
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The PART III is Motor sections.
次要结局
- Gut microbiota(From Baseline to 12 Weeks Assessed)
- Visual Analogue Scale for GI symptoms, VAS-GI(From Baseline to 12 Weeks Assessed)
- Clinical Global Impression scales of Severity rated by clinician（CGI）(From Baseline to 12 Weeks Assessed)
- Difference in Oxidative stress - blood level of HSCRP(From Baseline to 12 Weeks Assessed)
- UPDRS I-IV(From Baseline to 12 Weeks Assessed)
- Q-LES-Q(From Baseline to 12 Weeks Assessed)
- PGI-C(From Baseline to 12 Weeks Assessed)
- brain-derived neurotropic factor (BDNF)(From Baseline to 12 Weeks Assessed)
- PHQ-9(From Baseline to 12 Weeks Assessed)
- Differences in the State and Trait Anxiety Index (STAI)(From Baseline to 12 Weeks Assessed)
- Level of Growth Differentiation Factor-15(From Baseline to 12 Weeks Assessed)
研究者
Sheylin Wu
Principal Investigator
Changhua Christian Hospital