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

NCT03373721 | Recruiting

• 1 other identifier: XH-17-009
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

About 50 preterm infants and 50 full-term healthy infants

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Related Publications (1)

• Jia J, Shuai M, Yan W, Tang Q, Wang B, Tang W, Wang P, Zhang T, Yang S, Zhang Y, Liu Q, Fu Y, Cai W, Zheng JS. Conserved Covarying Gut Microbial Network in Preterm Infants and Childhood Growth During the First 5 Years of Life: A Prospective Cohort Study. Am J Clin Nutr. 2023 Sep;118(3):561-571. doi: 10.1016/j.ajcnut.2023.07.019. Epub 2023 Jul 29.

  PMID: 37517614 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples of the recruited infants

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jie Jia, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jia, PhD

CONTACT

0086-13122322289; jie.jia@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Study Start: July 20, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 20, 2028
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (1)