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

Preterm Infant Clinical Trial

Official title:

Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373721
• Other study ID #: XH-17-009
• Status: Recruiting
• Start date: July 20, 2014
• Est. completion date: December 20, 2028

Study information

• Verified date: April 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Jie Jia, PhD
• Phone: 0086-13122322289
• Email: jie.jia[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 20, 2028
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiome
• Premature Birth
• Preterm Infant

Locations

Country	Name	City	State
China	Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in gut microbiota over time and in relation to antibiotic treatment	Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants	0-7 years after birth