Clinical trial NCT03396198: A Cohort Analysis Study of Intestinal Flora in Infants
Official title: An Observational Study of Intestinal Flora in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Microbiome
Keywords: Gastrointestinal Microbiome
Infants
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 100
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of the city of Hangzhou

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.

Eligibility criteria: Inclusion Criteria:

* Healthy newborns

Exclusion Criteria:

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

Primary outcomes:
measure: Intestinal Flora Sequencing
timeFrame: Intestinal Flora Sequencing Change from Baseline to 12 months after Birth
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Gastroenterology Laboratory
state: Zhe Jiang
Study officials:
affiliation: The Affiliated Children's Hospital of Zhejiang University Medical School
name: Mizu Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
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