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NCT Number: NCT06152835

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location status: Recruiting

Location contact

Roberto Berni Canani, MD, PhD

CONTACT

[email protected]

0817462680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data and breast milk samples collection

Other

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

Primary outcomes

  1. To analyze the contents of breast milk completely and at different times during the feeding and during the day.

    Time frame: 36 months

    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.

  2. Nutritional composition analysis (macro and micronutrients)

    Time frame: 36 months

    Mass spectrometry analyzes will be performed.

  3. Metagenomic analysis

    Time frame: 36 months

    Shotgun analysis will be performed.

  4. Metabolomics analysis

    Time frame: 36 months

    Mass spectrometry analyzes will be performed.

  5. MicroRNA analysis

    Time frame: 36 months

    TaqMan MicroRNA Assays will be adopted.

  6. Compounds derived from ultraprocessed foods and from packaging analyses

    Time frame: 36 months

    Mass spectrometry analyzes will be performed.

Secondary outcomes

  1. To analyze the environmental factors capable of modulating the composition of breast milk

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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