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

NCT06157346 | Completed

• 1 other identifier: SYJQ-001
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health; Children, Only; Gut Microbiota

Outcome Measures

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

  0-7 days after enrolled

Secondary Outcomes (1)

• Intestinal microbiome metabolites analysis

  0-7 days after enrolled

Other Outcomes (3)

• 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

  0-7 days after enrolled

• The percentile number of head circumference of children at different altitudes

  0-7 days after enrolled

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

heathy children aged 1-3 years old

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

faeces

Study Officials

• Chundi Xu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 5, 2023
• Study Start: October 16, 2023
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: August 18, 2026

Record last verified: 2025-03

Locations

CN (1)