NCT04611945

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

October 9, 2020

Last Update Submit

April 26, 2022

Conditions

MicrobiomeGlucose MetabolismMoodEnvironment

Outcome Measures

Primary Outcomes (2)

  • Gut microbial abundant change

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

    Day 1, day 10, day 16, day 23, day 28

  • Tongue coating microbial abundant change

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

    Day 1, day 10, day 16, day 23, day 28

Secondary Outcomes (8)

  • Mood states change over 4 weeks

    Day 1, day 10, day 16, day 23, day 30

  • Health-related quality of life change over the one-month sailing

    Day 1, 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

  • Weight change

    Day 1, day 10, day 16, day 23, day 28

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who will sail by Shenkuo, a scientific research ship, December 2020.

You may qualify if:

  • Willingness and capability to complete the study protocol

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, white cells, urine, faeces, tongue coating, skin microbiome

Study Officials

  • Ju-Sheng Zheng

    Westlake University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

November 2, 2020

Study Start

November 10, 2020

Primary Completion

January 31, 2022

Study Completion

April 26, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

CN(1)