NCT02207140已完成早期 1 期
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
Gabriella C. van Zanten2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fecal Clostridium difficile numbers
研究概览
简要总结
The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 75 years or more
排除标准
- •Individuals with chronic bowel diseases
- •Individuals with severe immunosuppression
- •Individuals with dementia
- •Individuals who are terminally ill
- •If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
- •Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
- •Subjects with a history of substance abuse
- •Subjects that, in the investigators opinion, are not expected to complete the study succesfully
结局指标
主要结局
Fecal Clostridium difficile numbers
时间窗: 24 weeks
次要结局
- fecal microbial composition(24 weeks)
研究者
Gabriella C. van Zanten
Postdoc
University of Copenhagen
研究点 (2)
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