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

NCT05901896 | Unknown

• 1 other identifier: Gut Microbiota001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota

Outcome Measures

Primary Outcomes (4)

• the bacterial composition difference using 16S rRNA sequencing 1

  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.

  one month after relocation

• the bacterial composition difference using 16S rRNA sequencing 2

  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.

  three month after relocation

• the bacterial composition difference using 16S rRNA sequencing 3

  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.

  six month after relocation

• the bacterial composition difference using 16S rRNA sequencing 4

  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.

  twelve month after relocation

Secondary Outcomes (4)

• 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 Arms (2)

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.

Other: there are 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.

Other: there are no intervention

Interventions

there are no intervention OTHER

no intervention

control group; study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Sites (1)

Liaocheng people's hospital

Liaocheng, Shandong, 252000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool samples

Study Design

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

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 13, 2023
• Study Start: June 15, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-02

Locations

CN (1)