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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152835
• Other study ID #: 14/2023
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: July 24, 2026

Study information

• Verified date: December 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 24, 2026
• Est. primary completion date: July 24, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Data and breast milk samples collection
Breast milk samples and, clinical, anamnestic and lifestyle data collection

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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