Microbial Composition of Breast Milk Collected From Healthy Turkish Women

August 27, 2019 updated by: F. Gülhan Samur, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • HACETTEPE UNIVERSİTY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

20 healthy women who were at 16. day postpartum

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 16 day postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Turkish Society of Clinical Entral & Parenteral Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2018

Primary Completion (Actual)

September 5, 2018

Study Completion (Actual)

July 5, 2019

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hacettepe Nutrition Diet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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