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NCT Number: NCT03373721

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

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Gut Microbiome Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Jie Jia, PhD

CONTACT

[email protected]

008613122322289

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm infants

  • gestational age <37 weeks;
  • no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
  • hospital stay > 7 days;

Exclusion criteria

  • NICU stay less than 7 days
  • Necrotizing enterocolitis infant

Control group:

  • Full-term healthy infants;
  • gestational age >37 weeks;
  • vaginally born;
  • no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.

Treatment and study plan

Primary outcomes

  1. changes in gut microbiota over time and in relation to antibiotic treatment

    Time frame: 0-7 years after birth

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Jia, PhD

CONTACT

[email protected]

0086-13122322289

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2028
First posted
Dec 14, 2017
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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