NCT04855344Unknown不适用
Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in gut microbiota
研究概览
简要总结
This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age;
- •Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr);
- •Deep brain stimulator therapy;
- •Sign the informed consent.
排除标准
- •Use of probiotics or probiotics during the study;
- •Use antibiotics against intestinal bacteria at present or within the last 1 month;
- •With cognitive dysfunction or mental illness;
- •With severe diseases or is not expected to survive for more than a year;
- •A history of gastrointestinal surgery;
- •AIDS patients, hepatitis B/C positive.
结局指标
主要结局
Change in gut microbiota
时间窗: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Analyzed by 16sRNA sequencing of feces
次要结局
- Frequency of defecation(Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy)
- Dosage of anti-Parkinson's agent(Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy)
- Change in blood biomarkers of neuroinflammation and alpha-synuclein(Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy)
- Change in the score of Unified Parkinson's Disease Rating Scales(Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy)
- Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)(Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy)
研究者
研究点 (1)
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