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NCT Number: NCT06157346

Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude

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.

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location status: Recruiting

Location contact

Xinqiong Wang

CONTACT

[email protected]

0086-021-64370045 ext. 600905

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinqiong Wang

CONTACT

[email protected]

0086-021-64370045 ext. 600905

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude in Diqing Tibetan Autonomous Prefecture, Yunnan Province

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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