- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157346
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude in Diqing Tibetan Autonomous Prefecture, Yunnan Province
Study Overview
Status
Conditions
Detailed Description
This observational study aims to gain a deeper understanding of the interactions and influence of microbes on the human body. By comparing the gut microbiota composition of children in different regions, at varying altitudes, and with distinct dietary habits, the study aims to answer two key questions:
What are the characteristics of children's gut microbiota in different regions, at different altitudes, and with different dietary habits? What is the relationship between the development and maturation process of children's gut microbiota in plateau areas and their immunity, metabolism, and growth? Participants will be asked to provide fecal samples for analysis during the study. They may also be asked to answer questionnaires about their lifestyle factors such as diet and physical activity. The comparison group is included, researchers will compare the gut microbiota composition and diversity of children in low-altitude areas with those in plateau areas to assess any differences in their gut microbiota profiles. By comparing these differences, the mechanism of action of children's gut microbiota on immunity, growth and development can be further analyzed. The findings of this study aim to provide a scientific basis for improving children's health in plateau areas.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xinqiong Wang
- Phone Number: 600905 0086-021-64370045
- Email: wxq11671@rjh.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 021
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
-
Contact:
- Xinqiong Wang
- Phone Number: 600905 0086-021-64370045
- Email: wxq11671@rjh.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 1-3 years old
- Both men and women;
- The child's legal guardian signed the informed consent to participate in the study.
- The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process
Exclusion Criteria:
- Probiotics or antibiotics within 1 month
- Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator
- Unstable vital signs;
- Have other underlying medical conditions
- Individuals deemed unsuitable for this clinical trial.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
High-altitude
Children live in a high-altitude area of more than 3000 meters.
|
Low-altitude
Children live in a low-altitude area of less than 500 meters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal microbiome analysis by high-throughput metagenomic
Time Frame: 0-7 days after enrolled
|
The fecal samples from all participants will be collected and subjected to high-throughput metagenomic sequencing in order to elucidate the characteristics and composition of the intestinal microbiome in children residing at different altitudes
|
0-7 days after enrolled
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal microbiome metabolites analysis
Time Frame: 0-7 days after enrolled
|
This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MS) non-targeted metabolomics to analyze the metabolites of the intestinal microbiome and compare the differences in these metabolites among children at different altitudes.
|
0-7 days after enrolled
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentile number of height of children at different altitudes
Time Frame: 0-7 days after enrolled
|
Compare the Percentile number of height of children at different altitudes
|
0-7 days after enrolled
|
The percentile number of weight of children at different altitudes
Time Frame: 0-7 days after enrolled
|
Compare the Percentile number of weight of children at different altitudes
|
0-7 days after enrolled
|
The percentile number of head circumference of children at different altitudes
Time Frame: 0-7 days after enrolled
|
Compare the Percentile number of head circumference of children at different altitudes
|
0-7 days after enrolled
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chundi Xu, Ruijin Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SYJQ-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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