The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data and breast milk samples collection.
- Who it may be relevant to
- Registry conditions: Breastfeeding. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Data and breast milk samples collection
Breast milk samples and, clinical, anamnestic and lifestyle data collection
Primary outcome measures
- To analyze the contents of breast milk completely and at different times during the feeding and during the day. [Time frame: 36 months]
- Nutritional composition analysis (macro and micronutrients) [Time frame: 36 months]
- Metagenomic analysis [Time frame: 36 months]
- Metabolomics analysis [Time frame: 36 months]
- MicroRNA analysis [Time frame: 36 months]
- Compounds derived from ultraprocessed foods and from packaging analyses [Time frame: 36 months]
Secondary outcome measures (1)
- To analyze the environmental factors capable of modulating the composition of breast milk [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
- Written informed consent
Exclusion criteria
- Non-Italian women;
- Age <20 and >40 years;
- Mothers of children born preterm;
- Non-exclusive breastfeeding;
- Mothers suffering from chronic diseases:
- malignancies;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Department of Traslational Medical Science - University of Naples Federico II — Naples
Identifiers
NCT: NCT06152835 · 14/2023