Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complete bowel movements
研究概览
简要总结
Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of constipation according to Roma III criteria
- •complete bowel movements per week <3
- •total bowel movements per week <6
- •written informed consent
排除标准
- •report of loose (mushy) or watery stool in the absence of laxative use
- •ongoing artificial nutrition
- •lactose intolerance
- •chronic inflammatory bowel disease
- •previous abdominal surgery
- •use of anti-cholinergics
- •use of antibiotics in the 6 weeks before baseline visit
- •Radio- chemotherapy
- •Cognitive decline (Mini Mental State Examination <27)
结局指标
主要结局
Complete bowel movements
时间窗: 4 weeks
Change in the mean number of complete spontaneous bowel movements
次要结局
- Stool consistency(4 weeks)
- Number of bowel movements(4 weeks)
- Treatment satisfaction(4 weeks)
- Frequency of three or more complete bowel movements(4 weeks)
- Laxative use(4 weeks)
- Treatment continuation(4 weeks)
- Increase in one or more complete bowel movements(4 weeks)
研究者
Emanuele Cereda
Co-project Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia