Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preterm Infant, Gut Microbiome. Basic parameters: 1 Day — 4 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
Overview
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 .
Primary outcome measures
- changes in gut microbiota over time and in relation to antibiotic treatment [Time frame: 0-7 years after birth]
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;
- vaginally born;
- no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of — Shanghai
Publications
- 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
Identifiers
NCT: NCT03373721 · XH-17-009