The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
Launched by FEDERICO II UNIVERSITY · Nov 22, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
The BuKoBc Project is a clinical trial aimed at understanding the composition of breast milk and how it may change based on different factors, such as the time of day and environmental influences. This study is important because breast milk is known to be the best source of nutrition for babies, providing essential nutrients and protective benefits that can support their health now and in the future. By examining breast milk in detail, researchers hope to create guidelines for what infants need nutritionally, especially for those who cannot be breastfed, and develop strategies to help breastfeeding mothers improve their milk's quality.
To participate in this trial, women must be Italian, aged between 20 and 40 years old, and exclusively breastfeeding a full-term baby. Unfortunately, mothers with certain health conditions or those who have not exclusively breastfed their infants will not be eligible. If you qualify, you can expect to contribute valuable information that may help future mothers and babies, while also learning more about the factors that influence breast milk. The study is currently recruiting participants, and your involvement could make a difference in the understanding of infant nutrition.
Gender
FEMALE
Eligibility criteria
- 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.
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Naples, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported