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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972214
• Other study ID #: 2021-03-062-004
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2021
• Source: CHA University
• Contact: Hye-Rim Kim, MD
• Phone: 82-10-3676-7097
• Email: hei23[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical center	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intestinal microbiome composition according to the type of feeding	comparison of intestinal microbiome with 16s RNA gene specific sequencing in stool	within 24 hours after birth
Primary	intestinal microbiome composition according to the type of feeding	comparison of intestinal microbiome with 16s RNA gene specific sequencing	2 weeks after birth
Primary	intestinal microbiome composition according to the type of feeding	comparison of intestinal microbiome with 16s RNA gene specific sequencing	4 weeks after birth