NCT03373721 Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
| NCT ID | NCT03373721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Preterm Infant |
| Study Type | OBSERVATIONAL |
| Enrollment | 102 participants |
| Start Date | 2014-07-20 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 102 participants in total. It began in 2014-07-20 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Jie Jia, PhD
PRINCIPAL INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT03373721 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 4 Months, studying Preterm Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03373721 currently recruiting?
Yes, NCT03373721 is actively recruiting participants. Contact the research team at jie.jia@shsmu.edu.cn for enrollment information.
Where is the NCT03373721 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT03373721 clinical trial?
NCT03373721 is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The principal investigator is Jie Jia, PhD at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 102 participants.