Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- motor parkinsonian symptoms
研究概览
简要总结
this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.
详细描述
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.
this study include one group of PD patients that will receive FMT. two other groups will serve as controls:
- PD patients that will not receive FMT
- healthy people who live with PD patients in the same house and share similar surrounding
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
- •Subjects complaining of constipation .
- •Subjects who did not perform a screening colonoscopy for colon cancer.
- •Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.
排除标准
- •Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
- •Subjects who already underwent a screening colonoscopy for colon cancer.
- •Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
结局指标
主要结局
motor parkinsonian symptoms
时间窗: Change from baseline motor difficulties at 6 months
motor symptoms assessed by UPDRS III questionaire
constipation level
时间窗: Change from baseline constipation level at 6 months
constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).
次要结局
未报告次要终点
研究者
ARIK SEGAL MD
Principal Investigator
Soroka University Medical Center