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

NCT06152835 | Recruiting

• 1 other identifier: 14/2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• To analyze the environmental factors capable of modulating the composition of breast milk

  36 months

Study Arms (1)

Breastfeeding Italian women

Italian women, aged 20-40 years who breastfeed children born at full term

Other: Data and breast milk samples collection

Interventions

Data and breast milk samples collection OTHER

Breast milk samples and, clinical, anamnestic and lifestyle data collection

Breastfeeding Italian women

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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".

You may qualify if:

• Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
• Written informed consent

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD, Professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)