BreastfeedingNCT06152835
The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
An observational study of Breastfeeding, run by Federico II University at 1 site in Italy.
Trial summary
Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Data and breast milk samples collection
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2023to 24 Jul 2026
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 100 Italian women, aged 20-40 years, who breastfed children born at full term, observed at the specialist pediatric clinics of the "Federico II" University Hospital of Naples, of the "La Sapienza University of Rome", of the "La Statale University of Milan", the "University of Pisa" and the "University of Verona".
Who may be able to join
- Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
- Written informed consent
Who cannot join
- Non-Italian women;
- Age <20 and >40 years;
- Mothers of children born preterm;
- Non-exclusive breastfeeding;
- Mothers suffering from chronic diseases:
- malignancies;
Show all 17Show fewer
- immunodeficiencies;
- chronic infections;
- autoimmune diseases;
- chronic inflammatory intestinal diseases;
- celiac disease;
- genetic-metabolic diseases;
- cystic fibrosis;
- chronic lung diseases;
- malformations of the cardiovascular/respiratory/gastrointestinal system;
- neuropsychiatric disorders;
- neurological diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. According to the guidelines of the World Health Organization (WHO), exclusive feeding with breast milk should be conducted until the end of 6 months of life and should be continued in the following months with the simultaneous introduction of complementary foods. Several evidence demonstrates that breast milk intake is associated with positive health outcomes, both during infancy and later in the life. Given the protective role of breast milk for the health of the child and the future adult, studying its content is of fundamental importance to have an integrated vision of the biological effects of its components on the child health, and of the factors that are able to modulate its composition. The "Building a Deeper Knowledge on Breast Milk Composition" (BuKoBc) project was designed to study the content of human milk in its entirety and at different times during the feeding and day, also in relation to environmental factors capable of modulating its composition. The results of this study may provide data on optimal reference ranges for nutrient intake in breastfed infants and may provide guidance for defining optimal nutrient intake for infants who cannot be breastfed. Furthermore, the in-depth study of the environmental factors capable of influencing the composition of breast milk will allow the development of nutritional intervention strategies for the breastfeeding mother in order to positively modulate the composition of her milk.
- Conditions
- Breastfeeding
- Being tested
- Data and breast milk samples collection
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data and breast milk samples collectionOther
Breast milk samples and, clinical, anamnestic and lifestyle data collection
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Italian women | Italian women, aged 20-40 years who breastfeed children born at full term Receives: Other: Data and breast milk samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the contents of breast milk completely and at different times during the feeding and during the day.
6 milk samples of at least 5 ml each will be collected at the beginning and end of the morning feeding, at the beginning and end of the afternoon feeding, and at the beginning and end of the evening feeding.
Measured: 36 months
Nutritional composition analysis (macro and micronutrients)
Mass spectrometry analyzes will be performed.
Measured: 36 months
Metagenomic analysis
Shotgun analysis will be performed.
Measured: 36 months
Metabolomics analysis
Mass spectrometry analyzes will be performed.
Measured: 36 months
MicroRNA analysis
TaqMan MicroRNA Assays will be adopted.
Measured: 36 months
Compounds derived from ultraprocessed foods and from packaging analyses
Mass spectrometry analyzes will be performed.
Measured: 36 months
Secondary outcomes (1)
To analyze the environmental factors capable of modulating the composition of breast milk
Maternal energy and nutrient intake, maternal ultra-processed food intake, level of adherence to the Mediterranean Diet, nutritional status, body composition, lifestyle, level of physical activity, level of education, intake of medications, food supplements, prebiotics, probiotics and synbiotics, consumption of alcohol, caffeine and tobacco will be evaluated.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152835
- Sponsor's protocol ID
- 14/2023
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
- ClinicalTrials.gov ID
- NCT06152835
- Acronym / sponsor ID
- 14/2023
- Conditions
- Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 1 Dec 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.
Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. According to the guidelines of the World Health Organization (WHO), exclusive feeding with breast milk should be conducted until the end of 6 months of life and should be continued in the following months with the simultaneous introduction of complementary foods. Several evidence demonstrates that breast milk intake is associated with positive health outcomes, both during infancy and later in the life. Given the protective role of breast milk for the health of the child and the future adult, studying its content is of fundamental importance to have an integrated vision of the biological effects of its components on the child health, and of the factors that are able to modulate its composition. The "Building a Deeper Knowledge on Breast Milk Composition" (BuKoBc) project was designed to study the content of human milk in its entirety and at different times during the feeding and day, also in relation to environmental factors capable of modulating its composition. The results of this study may provide data on optimal reference ranges for nutrient intake in breastfed infants and may provide guidance for defining optimal nutrient intake for infants who cannot be breastfed. Furthermore, the in-depth study of the environmental factors capable of influencing the composition of breast milk will allow the development of nutritional intervention strategies for the breastfeeding mother in order to positively modulate the composition of her milk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Italian women | – | Other: Data and breast milk samples collectionItalian women, aged 20-40 years who breastfeed children born at full term |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 100 Italian women, aged 20-40 years, who breastfed children born at full term, observed at the specialist pediatric clinics of the "Federico II" University Hospital of Naples, of the "La Sapienza University of Rome", of the "La Statale University of Milan", the "University of Pisa" and the "University of Verona".
Key inclusion criteria (2 listed)
- Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
- Written informed consent
Key exclusion criteria (17 listed)
- Non-Italian women;
- Age <20 and >40 years;
- Mothers of children born preterm;
- Non-exclusive breastfeeding;
- Mothers suffering from chronic diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data and breast milk samples collectionBreast milk samples and, clinical, anamnestic and lifestyle data collection | Other | Breastfeeding Italian women |
Primary outcome
To analyze the contents of breast milk completely and at different times during the feeding and during the day.
Time frame: 36 months
6 milk samples of at least 5 ml each will be collected at the beginning and end of the morning feeding, at the beginning and end of the afternoon feeding, and at the beginning and end of the evening feeding.
Nutritional composition analysis (macro and micronutrients)
Time frame: 36 months
Mass spectrometry analyzes will be performed.
Metagenomic analysis
Time frame: 36 months
Shotgun analysis will be performed.
Metabolomics analysis
Time frame: 36 months
Mass spectrometry analyzes will be performed.
MicroRNA analysis
Time frame: 36 months
TaqMan MicroRNA Assays will be adopted.
Compounds derived from ultraprocessed foods and from packaging analyses
Time frame: 36 months
Mass spectrometry analyzes will be performed.
1 secondary outcome
To analyze the environmental factors capable of modulating the composition of breast milk
Time frame: 36 months
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 1 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Breastfeeding, run by Federico II University at 1 site in Italy.
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 2 inclusion and 17 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 1 Sep 2026. 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 Italy. 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?
To analyze the contents of breast milk completely and at different times during the feeding and during the day. (time frame: 36 months). The study lists 6 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 1 Sep 2026.