Gut MicrobiotaNCT05901896
Temporal Changes in the Gut Microbiota Before and After Migrating to High Altitude
An observational study of Gut Microbiota, run by Liaocheng People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Volunteers in good health, without any diagnosed chronic diseases or gastrointestinal disorders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Changes in Gut Microbiota of Healthy Adults Before and After Migrating to High Altitude: a Longitudinal Study
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.
Read the 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.
- Conditions
- Gut Microbiota
- Being tested
- there are no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there are no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: there are no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: twelve month after relocation
Secondary outcomes (4)
the bacterial composition difference using 16S rRNA sequencing 5
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.
Measured: one month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 6
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.
Measured: three month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 7
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.
Measured: six month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 8
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.
Measured: twelve month after returning to Liaocheng City from Gangcha County.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start15 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901896
- Sponsor's protocol ID
- Gut Microbiota001
- Status last verified
- Feb 2023
- First submitted
- 17 May 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Changes in Gut Microbiota of Healthy Adults Before and After Migrating to High Altitude: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT05901896
- Acronym / sponsor ID
- Gut Microbiota001
- Conditions
- Gut Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: there are no interventionThe 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. |
| control group | – | Other: there are no interventionFive healthy residents living on the high-altitude region , matched 1:1 by age, gender, and race, will serve as control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Volunteers in good health, without any diagnosed chronic diseases or gastrointestinal disorders.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there are no interventionno intervention | Other | control group, study group |
Primary outcome
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 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 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.
4 secondary outcomes
the bacterial composition difference using 16S rRNA sequencing 5
Time frame: one month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 6
Time frame: three month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 7
Time frame: six month after returning to Liaocheng City from Gangcha County.
the bacterial composition difference using 16S rRNA sequencing 8
Time frame: twelve month after returning to Liaocheng City from Gangcha County.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gut Microbiota
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingObservational study
Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Non-GI Cancers, Cancer of Gastrointestinal Tract
Recruiting
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota, run by Liaocheng People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the bacterial composition difference using 16S rRNA sequencing 1 (time frame: one month after relocation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.