Conserved Covarying Gut Microbial Network in Preterm Infants and Childhood Growth During the First 5 Years of Life: A Prospective Cohort Study.
Jie Jia, Menglei Shuai, Weihui Yan...
https://pubmed.ncbi.nlm.nih.gov/37517614Actively Recruiting
Age: 1Day - 4Months
All Genders
Healthy Volunteers
ID03373721
Gut Microbial Succession of Preterm and Full-term Infants During Early Life
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-04-17
102
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the development of gut bacteria in preterm and full-term infants from birth to 90 days old. The goal is to understand how the gut microbiome forms over time in these two groups and to identify important clinical factors, like antibiotic use, that may influence this process. They believe that the gut bacteria in preterm infants differ in diversity and makeup from those in full-term infants, partly due to antibiotic exposure. The study involves analyzing stool samples from 51 preterm infants and 50 full-term infants. These samples will undergo genetic sequencing to examine bacterial profiles, focusing on the V3-V4 region of the 16S rRNA gene. Researchers will compare the major bacterial groups over time while adjusting for factors such as gestational age and antibiotic use. This is an observational study that follows infants early in life without administering treatments. Participants will provide stool samples that are analyzed for changes in gut bacteria from birth up to 90 days of age. The primary focus is to track how the microbiome changes over time and how antibiotic treatments relate to these changes. The study includes infants born prematurely before 37 weeks and full-term infants born after 37 weeks via vaginal delivery. The total participation period covers the early months of life, with ongoing monitoring of microbial development.
CONDITIONS
Brief Title
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
Who Can Participate
Age: 1Day - 4Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Preterm infants with gestational age less than 37 weeks
- No gastrointestinal tract disorders, metabolic diseases, or viral hepatitis
- Hospital stay longer than 7 days
- Full-term healthy infants with gestational age 37 weeks or more
- Full-term infants born vaginally
- Infants between birth and 4 months old
You will not qualify if you...
- NICU stay less than 7 days
- Infants with necrotizing enterocolitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Sample Collection
Duration - Up to 7 years after birth
Participants provide stool samples that will be analyzed to study the gut microbiota development from birth up to 7 years.
Periodic sample collections as scheduled during the study period
Long-term Monitoring
Duration - Up to 7 years after birth
Participants are monitored to observe changes in gut microbiota over time and in relation to antibiotic treatment.
Follow-up visits and sample collections over several years
Trial Site Locations
Total: 1 location
1
Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
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Research Team
J
Jie Jia, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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