Breast Milk CollectionNCT02596295
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
An observational study of Breast Milk Collection, run by Enzymotec at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: General healthy lactating mothers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet
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.
- Conditions
- Breast Milk Collection
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mothers for term infants | Lactating mothers | |
| Mothers for preterm infants | Lactating mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of natural lipids in human breast milk of Israeli's mothers
exploratory study
Measured: 30-60 days after delivery
Secondary outcomes (1)
Maternal diet survey
exsploratory study
Measured: 30-60 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yael Lifshitz, PhD, Study director, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596295
- Sponsor's protocol ID
- HM001
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet
- ClinicalTrials.gov ID
- NCT02596295
- Acronym / sponsor ID
- HM001
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers for term infants | – | –Lactating mothers |
| Mothers for preterm infants | – | –Lactating mothers |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- General healthy lactating mothers
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of natural lipids in human breast milk of Israeli's mothers
Time frame: 30-60 days after delivery
exploratory study
1 secondary outcome
Maternal diet survey
Time frame: 30-60 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Lifshitz, PhD study director
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Enzymotec at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of natural lipids in human breast milk of Israeli's mothers (time frame: 30-60 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.