Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement after treatment
研究概览
简要总结
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance
详细描述
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV criteria.
- •Negative for colon cancer screening
- •Negative relevant additional screening or consultation whenever appropriate.
- •Ability of conforming to the study protocol.
- •Stable treatment for Parkinson's disease
排除标准
- •Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
- •Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- •Previous major abdominal surgeries.
- •Inability to conform with protocol.
- •Recent history or suspicion of alcohol abuse or drug addiction.
- •Previous participation in this study.
结局指标
主要结局
Improvement after treatment
时间窗: 12 WEEKS
"Improvement after treatment" was evaluated with a global rating-of-change scale (-7 to +7: -7 = extremely worsened, 0 = unchanged, +7 = extremely improved). "Improvement after treatment" was defined by an increase in the global rating-of-change scale of ≥2 points.
neuropsychological function
时间窗: 12 weeks
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD.The total NMSS score ranges from 0 to 360, the worst.
satisfaction with therapy
时间窗: 12 weeks
A "satisfaction with therapy" score (on a 7-point Likert scale: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = dissatisfied, 4 = partially satisfied, 5 = satisfied, 6 = very satisfied, 7 = extremely satisfied)
次要结局
- the Unified Parkinson Disease Rating Scale (UPDRS, italian version)(12 WEEKS)
- M-PAC SYM(12 WEEKS)
研究者
PAOLA IOVINO
Associate Professor
University of Salerno