Breast Milk, Composition, MicrobiomeBreast MilkNCT02332382
The Influence of Mother Nutrition on Breast Milk Microbiome
An observational study of Breast Milk, Composition, Microbiome, run by Sheba Medical Center.
Trial summary
The research subject Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk, Composition, Microbiome
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- How long will I take part?
- 3 Months
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy lactating women
Inclusion Criteria:Healthy lactating women, breast feeding for the first 3 months after delivery
Exclusion Criteria: No compliance, sickness, drug consumption
-
About this study
Official title: The Influence of Mother Nutrition on the Composition of Fatty Acid, Oligosacharides and Its Effect on Breast Milk Microbiome
The research subject
Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).
Read more
Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .
In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.
- Conditions
- Breast Milk, Composition, Microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast milk composition in relation to nutritional intake
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk, Composition, MicrobiomeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Yoram Bujanover MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332382
- Sponsor's protocol ID
- 1424-14-SMC
- Acronym
- Breast Milk
- Status last verified
- Jan 2015
- First submitted
- 4 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mother Nutrition on the Composition of Fatty Acid, Oligosacharides and Its Effect on Breast Milk Microbiome
- ClinicalTrials.gov ID
- NCT02332382
- Acronym / sponsor ID
- Breast Milk / 1424-14-SMC
- Conditions
- Breast Milk, Composition, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (estimated)
- First posted
- 6 Jan 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 research subject
Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).
Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .
In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy lactating women
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
Change in breast milk composition in relation to nutritional intake
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk, Composition, Microbiome, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in breast milk composition in relation to nutritional intake (time frame: 3 months). 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 6 Jan 2015.