The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition

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 Overview

• Status: Recruiting
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Data and breast milk samples collection

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: 0817462680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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".

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfeeding Italian women; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months
Nutritional composition analysis (macro and micronutrients)	Mass spectrometry analyzes will be performed.	36 months
Metagenomic analysis	Shotgun analysis will be performed.	36 months
Metabolomics analysis	Mass spectrometry analyzes will be performed.	36 months
MicroRNA analysis	TaqMan MicroRNA Assays will be adopted.	36 months
Compounds derived from ultraprocessed foods and from packaging analyses	Mass spectrometry analyzes will be performed.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 14/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No