A Cohort Analysis Study of Intestinal Flora in Infants

• Conditions: Gastrointestinal Microbiome

• Registration Number: NCT03396198
• Lead Sponsor: Mizu Jiang

Brief Summary

The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.

Detailed Description

The gastrointestinal microbiome is believed to be critically important for infant growth and development. As we all know, the gut microbiota can influence gut maturation, metabolic, immune and brain development in early life. Host genotype, gestational age, antibiotic use, mode of delivery, diet and the context in which the infant is born (rural vs urban, presence of siblings, pets and other factors) can influence the development of infant gut microbiota. In the early life stage, intestinal flora disorders may alter the host immune function and increase the susceptibility to immune or metabolic diseases.

This research intends to establish a birth cohort of healthy newborns. The influence factors of gastrointestinal microbiome will be investigated by means of questionnaire survey, specimen collection and high throughput sequencing analysis. What's more, the correlation of gut microbiome, infant growth as well as related diseases will be explored either. The results will provide constructive suggestions for the establishment of infant normal intestinal flora and play an indispensable role in exploring the occurrence, development and prevention of related diseases.

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Primary Completion: 2020-06-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02
• Study Completion: 2020-12-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy newborns

Exclusion Criteria

• Newborns with diseases such as congenital heart disease or congenital malformation and so on

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal Flora Sequencing	Intestinal Flora Sequencing Change from Baseline to 12 months after Birth	Intestinal Flora Sequencing

Trial Locations

Locations (1)

The Gastroenterology Laboratory; 🇨🇳 Hangzhou, Zhe Jiang, China