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

Breast Milk Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596295
• Other study ID #: HM001
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: February 1, 2018
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Milk Collection

Locations

Country	Name	City	State
Israel	Meir Hospital	Kfar Saba	State

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of natural lipids in human breast milk of Israeli's mothers	exploratory study	30-60 days after delivery
Secondary	Maternal diet survey	exsploratory study	30-60 days after delivery