An observational study in Breastfeeding, sponsored by Federico II University. Completed at 1 site in Italy. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Federico II University · Observational
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.
262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.
This study's enrollment of 100 is below the median of 177 across 48 observational studies indexed under Breast Feeding.
Browse Breast Feeding studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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".
Exclusion Criteria:
Italian women, aged 20-40 years who breastfeed children born at full term
Other: Data and breast milk samples collection
Breast milk samples and, clinical, anamnestic and lifestyle data collection
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.
Time frame: 36 months
Nutritional composition analysis (macro and micronutrients)
Mass spectrometry analyzes will be performed.
Time frame: 36 months
Metagenomic analysis
Shotgun analysis will be performed.
Time frame: 36 months
Metabolomics analysis
Mass spectrometry analyzes will be performed.
Time frame: 36 months
MicroRNA analysis
TaqMan MicroRNA Assays will be adopted.
Time frame: 36 months
Compounds derived from ultraprocessed foods and from packaging analyses
Mass spectrometry analyzes will be performed.
Time frame: 36 months
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.
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Federico II University