Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- TUG
研究概览
简要总结
This RCT study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.
详细描述
This RCT study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Modified Hoehn &Yahr stage, MHY 1-3
- •45-80 years old
- •at least 9 years education
排除标准
- •Patients on antibiotics within the preceding one month
- •Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
- •Have undergone surgery of liver, bladder, or gastrointestinal tract
- •Have current or history of inflammatory bowel disease
- •Have history of cancer
- •Known allergy to probiotics
- •Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
- •Have received deep brain stimulation
- •Patients receiving artificial enteral or intravenous nutrition
- •Diagnosed before 40 years old
- •Poor control of other chronic diseases
- •Not eligible judged by PI
结局指标
主要结局
TUG
时间窗: 12 weeks
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
UPDRS III
时间窗: 12 weeks
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.
MHY
时间窗: 12 weeks
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.
次要结局
- UPDRS I-IV(Baseline and Post-12 weeks)
- SCL-90-R(Baseline and Post-12 weeks)
- VAS-GI(Baseline and Post-12 weeks)
- CPSQI(Baseline and Post-12 weeks)
- PGIC(Post-12 weeks)
研究者
CHIN-SONG LU
Professor
Professor Lu Neurological Clinic