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Clinical Trials/NCT04072627
NCT04072627
Completed
Not Applicable

Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study

Hacettepe University1 site in 1 country20 target enrollmentMay 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microbial Community in Breast Milk
Sponsor
Hacettepe University
Enrollment
20
Locations
1
Primary Endpoint
Microbial abundance and diversity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Breast milk is an optimal source of nutrients for newborns as well as a potential source of bacteria for the intestinal microbiota. However, there are limited number of studies evaluating the relationship between maternal nutrition, breast milk and neonatal intestinal microbiota.

Detailed Description

The study was conducted on a total of 20 healthy women following at Obstetrics and Gynecology Department of Gülhane Education and Research Hospital in Ankara Health Sciences University. Sociodemographic characteristics, anthropometric measurements, breastfeeding characteristics were evaluated in the third trimester of the women who underwent routine prenatal care. Breast milk samples were obtained at 16.day postpartum during lactation.

Registry
clinicaltrials.gov
Start Date
May 5, 2018
End Date
July 5, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

F. Gülhan Samur

Prof. Dr.

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Singleton pregnancy
  • Age 19-35 years
  • At weeks of 30-36 gestation
  • No history of acute or chronic diseases
  • Term delivery

Exclusion Criteria

  • Alcohol use
  • Gestational diabetes
  • Type 1 and 2 diabetes
  • Preeclampsia
  • Polycystic ovary
  • Thyroid and parathyroid disease
  • Metabolic bone or kidney disease
  • Abnormal liver function
  • Multiple pregnancy
  • Premature and postmature labor

Outcomes

Primary Outcomes

Microbial abundance and diversity

Time Frame: at 16 day postpartum

The microbial composition of the breast milk samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis.

Study Sites (1)

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