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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT03373721

Collaborator

(none)

102

Enrollment

Location

113

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 20, 2014

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Preterm infants

gestational age <37 weeks;
no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
hospital stay > 7 days;

Exclusion criteria:

NICU stay less than 7 days
Necrotizing enterocolitis infant

Control group:

Full-term healthy infants;
gestational age >37 weeks;
vaginally born;
no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai		China

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT03373721

Other Study ID Numbers:

XH-17-009

First Posted:

Dec 14, 2017

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of May 17, 2022