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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02596295
Enrollment
120
Registered
2015-11-04
Start date
2015-10-31
Completion date
2017-08-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection

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.

Interventions

None listed

Sponsors

Enzymotec
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Analysis of natural lipids in human breast milk of Israeli's mothers30-60 days after deliveryexploratory study

Secondary

MeasureTime frameDescription
Maternal diet survey30-60 days after deliveryexsploratory study

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026