Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
The purpose of this study is to investigate the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.
详细描述
This 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 treatment 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with idiopathic Parkinson's Disease
- •According to the record of ON / OFF diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day.
- •Between ages of 40-80 years old.
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
结局指标
主要结局
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: Baseline to Week 12 assessed on medication
The UPDRS scores is a rating tool used to gauge the course of Parkinson's disease in patients. The minimum total score possible is 0 and the maximum total score possible is 199. Higher values represent a worse outcome.
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period
时间窗: Baseline to Week 12 assessed off medications
The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period
时间窗: Baseline to Week 12 assessed on medications
The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.
Change in Patient "ON-OFF" Diary Recording "OFF" Period
时间窗: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
"ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "OFF" period represent better outcome.
Change in Patient "ON-OFF" Diary Recording "ON" Period
时间窗: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Outcome Measure Description: "ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "ON" period represent worse outcome.
次要结局
- Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score(Baseline to Week 12 assessed on Medication)
- Patient Global Impression of Change (PGI-C)(Week 12 assessed on Medication)
- Change in The Parkinson's Disease Questionnaire (PDQ-39)(Baseline to Week 12 assessed on Medication)
- Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score(Baseline to Week 12 assessed on Medication)
- Change in The Parkinson's Disease Questionnaire (PDQ-39)(Baseline to Week 12 assessed on Medication)
- Patient Global Impression of Change (PGI-C)(Week 12 assessed on Medication)
研究者
CHIN-SONG LU
Professor
Professor Lu Neurological Clinic