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

Completed

• Conditions: Breast Milk Collection

• Registration Number: NCT02596295
• Lead Sponsor: Enzymotec

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of natural lipids in human breast milk of Israeli's mothers	30-60 days after delivery	exploratory study

Secondary Outcome Measures

Name	Time	Method
Maternal diet survey	30-60 days after delivery	exsploratory study

Trial Locations

Locations (1)

Meir Hospital; 🇮🇱 Kfar Saba, State, Israel