Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Change from baseline Gastrointestinal symptoms to 3months
研究概览
简要总结
The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.
详细描述
The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years
- •Informed consent signed by study participant or legal guardian
排除标准
- •Known gastrointestinal disease, with strictures, malignance's and ischemia.
- •Inflammatory bowel diseases (IBD)
- •Participation in other clinical trials in the past three months.
结局指标
主要结局
Change from baseline Gastrointestinal symptoms to 3months
时间窗: Baseline, at 2 months and at 3months/study end
Gastrointestinal discomfort will be assessed through the gastrointestinal symptoms rating score (GSRS), a clinical rating scale for gastrointestinal symptoms. The GSRS includes 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative.
次要结局
- Change in use of intestinal motility regulating substances during the 3-month intervention period(at baseline and end of study ( 3months))
研究者
Robert Brummer
Professor and Dean
Örebro University, Sweden