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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04972214
Other study ID # 2021-03-062-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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