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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infant; Gut Microbiome

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 .

• Study Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• Study Contact: Name: Jie Jia, PhD; Phone Number: 0086-13122322289; Email: jie.jia@shsmu.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Jie Jia, PhD; Phone Number: 008613122322289; Email: jie.jia@shsmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

About 50 preterm infants and 50 full-term healthy infants

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in gut microbiota over time and in relation to antibiotic treatment	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	0-7 years after birth

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jie Jia, PhD, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 20, 2028

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: XH-17-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No