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Clinical Trials/NCT03373721
NCT03373721
Recruiting
Not Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country102 target enrollmentJuly 20, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
102
Locations
1
Primary Endpoint
changes in gut microbiota over time and in relation to antibiotic treatment
Status
Recruiting
Last Updated
2 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
July 20, 2014
End Date
December 20, 2028
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

changes in gut microbiota over time and in relation to antibiotic treatment

Time Frame: 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

Study Sites (1)

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