Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-3
SponsorRuijin Hospital
About this trial
Microbes and the human body maintain a complex relationship of interaction and influence. Different regions, altitudes, and dietary habits have different degrees of influence on the composition of children's intestinal flora. Therefore, the development and maturation process of children's intestinal flora in plateau areas was discovered, and its relationship with children's immunity, metabolism, and growth was understood. The mechanism of action of children's intestinal flora on immunity, growth and development was further analyzed by comparing it with people in low-altitude areas, to provide a scientific basis for improving children's health in plateau areas.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
heathy children aged 1-3 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: High-altitude
Group B: Low-altitude
Trial outcomes
Primary outcomes
1
Intestinal microbiome analysis by high-throughput metagenomic
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
Time frame
0-7 days after enrolledSecondary outcomes
1
Intestinal microbiome metabolites analysis
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.
Time frame
0-7 days after enrolledOther outcomes
1
The percentile number of height of children at different altitudes
Compare the Percentile number of height of children at different altitudes
Time frame
0-7 days after enrolled2
The percentile number of weight of children at different altitudes
Compare the Percentile number of weight of children at different altitudes
Time frame
0-7 days after enrolled3
The percentile number of head circumference of children at different altitudes
Compare the Percentile number of head circumference of children at different altitudes
Time frame
0-7 days after enrolledSponsors and contacts
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Source ClinicalTrials.gov