The Influence of Mother Nutrition on Breast Milk Microbiome

Breast Milk, Composition, Microbiome Clinical Trial

— Breast Milk  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02332382
• Other study ID #: 1424-14-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 4, 2015
• Last updated: January 4, 2015
• Start date: February 2015

Study information

• Verified date: January 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Exclusion Criteria: No compliance, sickness, drug consumption

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Milk, Composition, Microbiome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breast milk composition in relation to nutritional intake		3 months	No