Actively Recruiting

Age: 1Year - 3Years
All Genders
Healthy Volunteers
ID06157346

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

Led by Ruijin Hospital · Updated on 2025-04-04

300

Participants Needed

1

Research Sites

34 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to understand how microbes interact with the human body, focusing on children's gut bacteria in different regions, altitudes, and diets. It studies the development and changes in gut bacteria of children living in high-altitude plateau areas and compares them with children living at low altitudes to explore links with immunity, metabolism, and growth. The goal is to provide scientific insights to improve children's health in high-altitude regions. Participants include children aged 1 to 3 years living either in high-altitude areas above 3000 meters or low-altitude areas below 500 meters. The study is observational and involves collecting fecal samples for gut microbiome and metabolite analysis within 7 days after enrollment. Researchers also use questionnaires to gather information on lifestyle, diet, and physical activity. During the study, children provide samples and may answer questions about their lifestyles. Researchers analyze the gut bacteria composition and metabolites to understand how these relate to growth and immune function. The study also monitors differences between children from high- and low-altitude regions. Participation involves cooperation from the child's legal guardian throughout the study process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 3Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1-3 years old
  • Both boys and girls
  • The child's legal guardian has signed informed consent to participate
  • The legal guardian agrees to follow study procedures and cooperate throughout the study
Not Eligible

You will not qualify if you...

  • Use of probiotics or antibiotics within the last month
  • Significant abnormalities in liver, kidney, nervous system, respiratory, or blood clotting functions
  • Unstable vital signs
  • Presence of other underlying medical conditions
  • Individuals considered unsuitable for the trial by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 0 to 7 days after enrollment

Participants provide fecal samples and answer questionnaires about lifestyle factors such as diet and physical activity to analyze gut microbiota composition and diversity.

1 to 2 visits for sample collection and questionnaires

Long-term Monitoring

Duration - Up to several months after initial evaluation

Participants are observed to assess the relationship between gut microbiota development and maturation with immunity, metabolism, and growth.

Additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 1 location

1

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 021

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Research Team

X

Xinqiong Wang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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