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Clinical Trials/NCT05901896
NCT05901896
Active, not recruiting
Not Applicable

Temporal Changes in Gut Microbiota of Healthy Adults Before and After Migrating to High Altitude: a Longitudinal Study

Liaocheng People's Hospital1 site in 1 country10 target enrollmentJune 15, 2023
ConditionsGut Microbiota

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Microbiota
Sponsor
Liaocheng People's Hospital
Enrollment
10
Locations
1
Primary Endpoint
the bacterial composition difference using 16S rRNA sequencing 3
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
July 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Liaocheng People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

the bacterial composition difference using 16S rRNA sequencing 3

Time Frame: six month after relocation

Alpha and beta diversity were calculated based on the rooted phylogenetic tree. Read classification to taxonomic profiles at four levels e.g., phylum, family, genus and species was compared between baseline and six month after relocation.

the bacterial composition difference using 16S rRNA sequencing 1

Time Frame: one month after relocation

Alpha and beta diversity were calculated based on the rooted phylogenetic tree. Read classification to taxonomic profiles at four levels e.g., phylum, family, genus and species was compared between baseline and one month after relocation.

the bacterial composition difference using 16S rRNA sequencing 2

Time Frame: three month after relocation

Alpha and beta diversity were calculated based on the rooted phylogenetic tree. Read classification to taxonomic profiles at four levels e.g., phylum, family, genus and species was compared between baseline and three month after relocation.

the bacterial composition difference using 16S rRNA sequencing 4

Time Frame: twelve month after relocation

Alpha and beta diversity were calculated based on the rooted phylogenetic tree. Read classification to taxonomic profiles at four levels e.g., phylum, family, genus and species was compared between baseline and twelve month after relocation.

Secondary Outcomes

  • the bacterial composition difference using 16S rRNA sequencing 5(one month after returning to Liaocheng City from Gangcha County.)
  • the bacterial composition difference using 16S rRNA sequencing 6(three month after returning to Liaocheng City from Gangcha County.)
  • the bacterial composition difference using 16S rRNA sequencing 7(six month after returning to Liaocheng City from Gangcha County.)
  • the bacterial composition difference using 16S rRNA sequencing 8(twelve month after returning to Liaocheng City from Gangcha County.)

Study Sites (1)

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