NCT02784145已完成不适用
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Bowel habits
研究概览
简要总结
The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:
- symptoms of constipation (assessed by clinical scores);
- fecal short chain fatty acid concentrations (measured by chromatography);
- gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed to participate
- •For patients: diagnosis of Parkinson Disease
排除标准
- •Use of antibiotics, steroids or probiotic supplements
- •Chronic or acute disorders of the gastrointestinal tract
- •History of gastrointestinal surgery (other than appendectomy)
- •For healthy controls: Family history of neurodegenerative disorders
结局指标
主要结局
Bowel habits
时间窗: 8 weeks
Number of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations
时间窗: 8 weeks
Number of patients with either a) increased, b.) unaltered or c) decreased concentration of short chain fatty acids in fecal samples at 8 weeks (compared to baseline)
Analysis of fecal microbiota composition
时间窗: 8 weeks
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
次要结局
未报告次要终点
研究者
Dr. Marcus Unger
PD Dr.
Universität des Saarlandes
研究点 (2)
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