Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03373721

Enrollment

102

Registered

2017-12-14

Start date

2014-07-20

Completion date

2028-12-20

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiome, Preterm Infant

Brief summary

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Detailed description

Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 4 Months

Healthy volunteers

Yes

Inclusion criteria

Preterm infants 1. gestational age \<37 weeks; 2. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis; 3. hospital stay \> 7 days;

Exclusion criteria

1. NICU stay less than 7 days 2. Necrotizing enterocolitis infant Control group: 1. Full-term healthy infants; 2. gestational age \>37 weeks; 3. vaginally born; 4. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.

Design outcomes

Primary

Measure	Time frame	Description
changes in gut microbiota over time and in relation to antibiotic treatment	0-7 years after birth	Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants

Countries

China

Contacts

Primary ContactJie Jia, PhD

jie.jia@shsmu.edu.cn0086-13122322289

Outcome results