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

NCT ID: NCT02596295

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Breast Milk Collection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers for term infants

Lactating mothers

No interventions assigned to this group

Mothers for preterm infants

Lactating mothers

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Enzymotec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yael Lifshitz, PhD

Role: STUDY_DIRECTOR

Employee

Locations

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Meir Hospital

Kfar Saba, State, Israel

Site Status

Countries

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Israel

Other Identifiers

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HM001

Identifier Type: -

Identifier Source: org_study_id

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