Actively Recruiting

Age: 1Day - 4Months
All Genders
Healthy Volunteers
NCT03373721

Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-04-17

102

Participants Needed

1

Research Sites

752 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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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

CONTACT

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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