Breast FeedingNCT05979532
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
An observational study of Breast Feeding and Milk, Human, run by Nutricia Research at 1 site in Netherlands.
Trial summary
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Milk, Human
- How many people
- 172 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2024to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 120 Lactating mothers who have the intention to breastfeed for at least 6 months and their newborns.
Who may be able to join
- Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.
- Age ≥ 18 years.
- Willingness to provide residual human milk.
- Living in proximity of NCRU (clinical site in NL).
- Dutch speaking and reading.
- Freezer -18°C available.
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- Having mobile phone, tablet, or computer available.
- Signed informed consent from the subject (pregnant woman).
- Signed informed consent from the other parent and/or legally acceptable representative, of the unborn baby(s), aged ≥ 18 years.
Who cannot join
- Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- Multiple pregnancy > 2.
- Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection).
- Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.
- Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site.
- Continuation exclusion criteria (after birth)
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- Stillbirth
- Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and/or growing normally based on the opinion of a health care professional and/or study physician.
- No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danone Nutricia Research N Research contact
Netherlands1 site, 1 recruiting
- Recruiting
Danone Nutricia Research
Utrecht, 3584CT
ncru.utrecht@danone.com
M. Visser
About this study
Official title: A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.
- Conditions
- Breast Feeding, Milk, Human
- Keywords
- Breast Feeding, Human milk, Research, Lactation, Human Milk Oligosaccharide, HMO
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
Measured: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
Laboratory analyses of Infant's faecal microbiome composition.
Measured: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start13 Feb 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979532
- Sponsor's protocol ID
- SBB21R&35943
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk
- ClinicalTrials.gov ID
- NCT05979532
- Acronym / sponsor ID
- SBB21R&35943
- Conditions
- Breast Feeding, Milk, Human
- Keywords
- Breast Feeding, Human milk, Research, Lactation, Human Milk Oligosaccharide, HMO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Aug 2023 (actual)
- 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 current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120 Lactating mothers who have the intention to breastfeed for at least 6 months and their newborns.
Key inclusion criteria (9 listed)
- Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.
- Age ≥ 18 years.
- Willingness to provide residual human milk.
- Living in proximity of NCRU (clinical site in NL).
- Dutch speaking and reading.
Key exclusion criteria (9 listed)
- Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- Multiple pregnancy > 2.
- Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection).
- Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.
- Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site.
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
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
Time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
Time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Laboratory analyses of Infant's faecal microbiome composition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Danone Nutricia Research N Research contact
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 Feeding and Milk, Human, run by Nutricia Research at 1 site in Netherlands.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Mar 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia Research N Research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters. (time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.). The study lists 2 primary outcomes in all. 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 15 Mar 2024.