The Influence of Mother Nutrition on Breast Milk Microbiome (Breast Milk)

January 4, 2015 updated by: Prof. Yoram Bujanover MD, Sheba Medical Center

The Influence of Mother Nutrition on the Composition of Fatty Acid, Oligosacharides and Its Effect on Breast Milk Microbiome

The research subject

Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).

Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .

In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

20

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy lactating women

Description

Inclusion Criteria:Healthy lactating women, breast feeding for the first 3 months after delivery

Exclusion Criteria: No compliance, sickness, drug consumption

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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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in breast milk composition in relation to nutritional intake
Time Frame: 3 months
3 months

Collaborators and Investigators

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

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

February 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 1424-14-SMC

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.

Clinical Trials on Breast Milk, Composition, Microbiome

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