Study for Evaluating the Impact of Continuous Consumption of Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Longitudinal changes in the number of LcS in feces
研究概览
简要总结
Human immune function and intestinal microbiota are suggested to be altered within long-duration stay in space. Accumulated evidences on earth support that Lacticaseibacillus paracasei strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight as well as intake of LcS on the international space station (ISS), on immune system and intestinal microbiota in astronauts.
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
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are scheduled to stay on the ISS for at least 3 months
- •Individuals who fully understand the study protocol and provide written informed consent for the study participation
排除标准
- •Individuals who routinely use antibiotic, laxative, and/or bowel regulating medicine
- •Individuals who participate in other research that competes with this study in terms of the purpose and field, e.g., study with dietary management or intake of bifidobacteria/lactic acid bacteria, oligosaccharides, antibiotic, laxative, and/or bowel regulating medicine
研究组 & 干预措施
Control group
LcS group
Consuming probiotic capsule
干预措施: Probiotic capsule (Dietary Supplement)
结局指标
主要结局
Longitudinal changes in the number of LcS in feces
时间窗: 9-18 months
Number of LcS in feces will be assessed by PMA-qPCR, during pre-flight, in-flight and post-flight.
Longitudinal changes in the level of immune markers
时间窗: 9-18 months
Levels of immune markers in blood/saliva will be assessed by ELISA and bioassay, during pre-flight, in-flight and post-flight.
Longitudinal changes in numbers and composition of intestinal microbiota
时间窗: 9-18 months
Numbers and composition of bacteria in feces will be assessed by RT-qPCR/qPCR and next generation sequencer analysis, during pre-flight, in-flight and post-flight.
次要结局
未报告次要终点