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OpenTrials
Completed

NCT Number: NCT04072627

Microbial Composition of Breast Milk Collected From Healthy Turkish Women

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.

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Key information

Conditions

Microbial Community in Breast Milk

Age range

20 year–31 year

Sex eligibility

Female

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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
  • Smoking
  • Gestational diabetes
  • Type 1 and 2 diabetes
  • Preeclampsia
  • Polycystic ovary
  • Syndrome
  • Thyroid and parathyroid disease
  • Metabolic bone or kidney disease
  • Abnormal liver function
  • Multiple pregnancy
  • Premature and postmature labor
  • Having chemotherapy
  • Taking drugs such as antibiotics and probiotics

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Turkish Society of Clinical Enteral and Parenteral Nutrition

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

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.