The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

• Conditions: Microbial Colonization

• Registration Number: NCT04972214
• Lead Sponsor: CHA University

Brief Summary

This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

Detailed Description

The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.

The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

Study Timeline

• Study Start: 2021-05-17
• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-27
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Very preterm infants (< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth

Exclusion Criteria

• Parents refuse to participate/sign informed consent
• Major congenital anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intestinal microbiome composition according to the type of feeding	4 weeks after birth	comparison of intestinal microbiome with 16s RNA gene specific sequencing

Trial Locations

Locations (1)

CHA Bundang Medical center; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of