Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 5, 2018
February 1, 2018
1.8 years
November 3, 2015
February 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Analysis of natural lipids in human breast milk of Israeli's mothers
exploratory study
30-60 days after delivery
Secondary Outcomes (1)
Maternal diet survey
30-60 days after delivery
Study Arms (2)
Mothers for term infants
Lactating mothers
Mothers for preterm infants
Lactating mothers
Eligibility Criteria
General healthy lactating mothers
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enzymoteclead
Study Sites (1)
Meir Hospital
Kfar Saba, State, 340000, Israel
Biospecimen
Human milk
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yael Lifshitz, PhD
Employee
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 4, 2015
Study Start
October 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02