Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-4
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
gestational age <37 weeks;
no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
hospital stay > 7 days;
Disqualifiers
NICU stay less than 7 days
Necrotizing enterocolitis infant
Full-term healthy infants;
gestational age >37 weeks;
Trial population
About 50 preterm infants and 50 full-term healthy infants
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
0-7 years after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov