Comparing gut microbiota in preterm and full-term infants
Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT03373721
This study looks at the differences in gut bacteria between preterm and full-term babies from birth to three months to see how things like antibiotic use affect their gut health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 1 Day to 4 Months |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03373721 on ClinicalTrials.gov |
What this trial studies
This observational study aims to longitudinally analyze the gut microbial establishment in a cohort of 51 preterm infants compared to 50 full-term infants from birth to 90 days of age. The researchers will sequence the V3-V4 region of 16S rRNA amplicons from stool samples to examine differences in microbial profiles. The study will also investigate key clinical factors, such as antibiotic usage, that may influence the development of the neonatal gut microbiome. A statistical model will be employed to compare the bacterial groups over time while adjusting for variables like gestational age.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 37 weeks of gestation and full-term infants born after 37 weeks without gastrointestinal disorders.
Not a fit: Patients who may not benefit from this study include those with gastrointestinal tract disorders, metabolic diseases, or who have experienced necrotizing enterocolitis.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of gut microbiome development in infants, potentially leading to improved health outcomes for preterm infants.
How similar studies have performed: Other studies have shown success in examining gut microbiota in infants, but this specific longitudinal approach comparing preterm and full-term infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Preterm infants 1. gestational age \<37 weeks; 2. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis; 3. hospital stay \> 7 days; Exclusion criteria: 1. NICU stay less than 7 days 2. Necrotizing enterocolitis infant Control group: 1. Full-term healthy infants; 2. gestational age \>37 weeks; 3. vaginally born; 4. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
Where this trial is running
Shanghai
- Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Jie Jia, PhD — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Jie Jia, PhD
- Email: jie.jia@shsmu.edu.cn
- Phone: 0086-13122322289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Infant, Gut Microbiome