Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet

The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be analysed and statistical analysis will look at correlation between demographics, dietary habits and milk composition.

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Key information

Conditions

Breast Milk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

15 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Meir Hospital

Kfar Saba, State, 340000, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) Mothers who intend to breastfeed the infant at least 80% of the daily feeding Mothers who can comply with the study requirements Mothers who sign the informed consent form in writing and can read and write Hebrew.

Exclusion criteria

Participation in any other studies involving investigational or marketed products Is consuming alcoholic drinks and is a drug abuser. Is suffering from chronic disease Presence of psychosis and severe post-partum depression. Mothers who have given birth to twins or multiples Mothers who received chemotherapy or isotopes during pregnancy investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.

Infants:

Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.

Treatment and study plan

Primary outcomes

Analysis of natural lipids in human breast milk of Israeli's mothers

Time frame: 30-60 days after delivery

exploratory study

Secondary outcomes

Maternal diet survey

Time frame: 30-60 days after delivery

exsploratory study

Sponsors and collaborators

Lead sponsor

Enzymotec

Industry

Registry information

Official study title

Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Nov 4, 2015
Registry last updated: Feb 5, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed