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Temporal Changes in the Gut Microbiota Before and After Migrating to High Altitude

NCT ID: NCT05901896

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2025-07-31

Brief Summary

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This prospective observational cohort study aims to learn about temporal changes in the gut microbiota before and after migrating to high altitudes in healthy participants. The main questions it aims to answer are:

* changes in the gut microbiome before and after migrating to high altitude.
* Do the migrants tend to share similar gut microbiota characteristics with the residents? Participants will detect 16S ribosomal RNA profiles from stool samples. Researchers will compare the residents with the migrants to see if gut microbiota characteristics are similar.

Detailed Description

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Changes in geographical environment can lead to alterations in the composition of the host's gut microbiota. However, the dynamic process and specific bacterial composition and patterns of change in the microbiota are not yet clear. In this study, the investigators conducted microbial analysis of the gut microbiota based on 16S rRNA amplicon sequencing in five healthy volunteers living in a plain area (Liaocheng City, Shandong Province) before and after their relocation to a high-altitude region (Gangcha County, Qinghai Province). Samples were collected at multiple time points, including 1 month, 3 months, 6 months, and 12 months after relocation, as well as 1 month, 3 months, 6 months, and 12 months after returning to Liaocheng City from Gangcha County. Additionally, a control group consisting of five local healthy individuals from Gangcha County (matched for age, gender, and ethnicity in a 1:1 ratio) was included. Dietary and lifestyle habits were investigated to determine the impact of environmental changes on the gut microbiota. The study aimed to analyze the diversity and abundance changes of the gut microbiota at different time points and identify specific bacterial compositions through clustering analysis.

Conditions

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Gut Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

The study group consists of five volunteers who originally lived in a plain area. They will be living in a high-altitude region for one year.

there are no intervention

Intervention Type OTHER

no intervention

control group

Five healthy residents living on the high-altitude region , matched 1:1 by age, gender, and race, will serve as control group.

there are no intervention

Intervention Type OTHER

no intervention

Interventions

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there are no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Volunteers in good health, without any diagnosed chronic diseases or gastrointestinal disorders.

Exclusion Criteria

recent antibiotic use; severe gastrointestinal infections; long-term use of immunosuppressive drugs or other medications that may impact the gut microbiota; history of gastrointestinal surgical interventions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liaocheng People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liaocheng people's hospital

Liaocheng, Shandong, China

Site Status

Countries

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China

Other Identifiers

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Gut Microbiota001

Identifier Type: -

Identifier Source: org_study_id