Comparing gut microbiota in preterm and full-term infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.