Research on the composition of breast milk
The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
This study looks at the makeup of breast milk from Italian women who exclusively breastfeed to see how it affects infant health and nutrition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06152835 on ClinicalTrials.gov |
What this trial studies
The BuKoBc Project aims to investigate the composition of breast milk to better understand its nutritional and protective benefits for infants. This observational study will collect data and breast milk samples from Italian women aged 20 to 40 who exclusively breastfeed healthy, term infants. By analyzing the components of breast milk, the project seeks to uncover how various factors influence its composition and the implications for child health. The findings could provide valuable insights into optimizing breastfeeding practices and improving infant nutrition.
Who should consider this trial
Good fit: Ideal candidates for this study are Italian women aged 20 to 40 who are exclusively breastfeeding healthy, term infants.
Not a fit: Patients who may not benefit from this study include non-Italian women, those with preterm infants, or mothers with chronic diseases.
Why it matters
Potential benefit: If successful, this research could enhance our understanding of breast milk's health benefits, leading to improved breastfeeding practices and better health outcomes for infants.
How similar studies have performed: While there have been studies on breast milk composition, this project aims to provide a deeper understanding, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.