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

Sponsor
Enzymotec (Industry)
Overall Status
Completed
CT.gov ID
NCT02596295
Collaborator
(none)
120
Enrollment
1
Location
22
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Aug 1, 2017
    Actual Study Completion Date :
    Aug 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Mothers for term infants

    Lactating mothers
    Mothers for preterm infants

    Lactating mothers

    Outcome Measures

    Primary Outcome Measures

    1. Analysis of natural lipids in human breast milk of Israeli's mothers [30-60 days after delivery]

      exploratory study

    Secondary Outcome Measures

    1. Maternal diet survey [30-60 days after delivery]

      exsploratory study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Meir Hospital Kfar Saba State Israel 340000

    Sponsors and Collaborators

    • Enzymotec

    Investigators

    • Study Director: Yael Lifshitz, PhD, Employee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enzymotec
    ClinicalTrials.gov Identifier:
    NCT02596295
    Other Study ID Numbers:
    • HM001
    First Posted:
    Nov 4, 2015
    Last Update Posted:
    Feb 5, 2018
    Last Verified:
    Feb 1, 2018

    Study Results

    No Results Posted as of Feb 5, 2018