跳至主要内容
临床试验/NCT04611945
NCT04611945已完成不适用

Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing

Westlake University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Gut microbial abundant change

研究概览

简要总结

Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.

详细描述

This study will recruit a number of participants who are going to sail for mariana trench from Shenzhen, China. Characteristics of the participants will be described by a series of index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the voyage and blood sample at the baseline will also be collected. Participants' mood states, health-related quality of life, fatigue score and sleep quality will be investigated with questionnaires throughout the 1-month period. Participants are asked to record diseases and symptoms, if any, when sailing. All the data will be used to analyse how microbiota change and be involved in human health during a voyage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness and capability to complete the study protocol

排除标准

  • Inability or unwillingness to approved to provide informed consent.
  • Women who are pregnant or lactating.

结局指标

主要结局

Gut microbial abundant change

时间窗: Day 1, day 10, day 16, day 23, day 28

Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.

Tongue coating microbial abundant change

时间窗: Day 1, day 10, day 16, day 23, day 28

Tongue coating microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.

次要结局

  • Health-related quality of life change over the one-month sailing(Day 1, day 30)
  • Fatigue score change(Day 1, day 10, day 16, day 23, day 30)
  • Weight change(Day 1, day 10, day 16, day 23, day 28)
  • Blood pressure change(Day 1, day 10, day 16, day 23, day 28)
  • Mood states change over 4 weeks(Day 1, day 10, day 16, day 23, day 30)
  • Sleep quality change over the one-month sailing(Day 1, day 30)
  • Short-chain fatty acids change(Day 1, day 10, day 16, day 23, day 28)
  • Skin microbial abundant change(Day 1, day 10, day 16, day 23, day 28)

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验