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

Sponsor
Liaocheng People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05901896
Collaborator
(none)
10
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: there are no intervention

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Temporal Changes in Gut Microbiota of Healthy Adults Before and After Migrating to High Altitude: a Longitudinal Study
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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
no intervention

Outcome Measures

Primary Outcome Measures

  1. the bacterial composition difference using 16S rRNA sequencing 1 [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.

  2. the bacterial composition difference using 16S rRNA sequencing 2 [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.

  3. the bacterial composition difference using 16S rRNA sequencing 3 [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.

  4. the bacterial composition difference using 16S rRNA sequencing 4 [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 Outcome Measures

  1. the bacterial composition difference using 16S rRNA sequencing 5 [one month after returning to Liaocheng City from Gangcha County.]

    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 months after returning to Liaocheng City from Gangcha County.

  2. the bacterial composition difference using 16S rRNA sequencing 6 [three month after returning to Liaocheng City from Gangcha County.]

    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 months after returning to Liaocheng City from Gangcha County.

  3. the bacterial composition difference using 16S rRNA sequencing 7 [six month after returning to Liaocheng City from Gangcha County.]

    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 months after returning to Liaocheng City from Gangcha County.

  4. the bacterial composition difference using 16S rRNA sequencing 8 [twelve month after returning to Liaocheng City from Gangcha County.]

    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 months after returning to Liaocheng City from Gangcha County.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Liaocheng People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liaocheng People's Hospital
ClinicalTrials.gov Identifier:
NCT05901896
Other Study ID Numbers:
  • Gut Microbiota001
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 13, 2023