Clinical trial NCT05901896: Temporal Changes in the Gut Microbiota Before and After Migrating to High Altitude
Official title: Temporal Changes in Gut Microbiota of Healthy Adults Before and After Migrating to High Altitude: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gut Microbiota
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the bacterial composition difference using 16S rRNA sequencing 1
timeFrame: one month after relocation
measure: the bacterial composition difference using 16S rRNA sequencing 2
timeFrame: three month after relocation
measure: the bacterial composition difference using 16S rRNA sequencing 3
timeFrame: six month after relocation
measure: the bacterial composition difference using 16S rRNA sequencing 4
timeFrame: twelve month after relocation
Secondary outcomes:
measure: the bacterial composition difference using 16S rRNA sequencing 5
timeFrame: one month after returning to Liaocheng City from Gangcha County.
measure: the bacterial composition difference using 16S rRNA sequencing 6
timeFrame: three month after returning to Liaocheng City from Gangcha County.
measure: the bacterial composition difference using 16S rRNA sequencing 7
timeFrame: six month after returning to Liaocheng City from Gangcha County.
measure: the bacterial composition difference using 16S rRNA sequencing 8
timeFrame: twelve month after returning to Liaocheng City from Gangcha County.
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng people's hospital
state: Shandong
Study officials:
References: