Analyzing proteins and peptides in human milk across different breastfeeding stages

Quantitative Proteomic Analysis of Minor Whey Proteins and Peptides of Human Milk Across Five Neonatal Groups Classified by Birth Weight During the Three Stages of Lactation

This study looks at the proteins in breast milk at different stages of breastfeeding to see how they help newborns, especially those who are born early or are smaller in size.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 0 Days to 120 Days
• Sex: All
• Sponsor: Maimónides Biomedical Research Institute of Córdoba (other)
• Locations: 2 sites (Córdoba, Córdoba and 1 other locations)
• Trial ID: NCT06787963 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the minor whey proteins and peptides present in human milk, which are crucial for the growth and development of newborns, particularly those who are low birthweight or preterm. By utilizing proteomic techniques, the study will analyze the protein variability and bioactive functions of these components across various lactation stages. The research will involve a longitudinal analysis of breastfeeding mothers and their infants, focusing on the relationship between the protein content in human milk and factors such as gestational age and birth weight. The findings could provide insights into the nutritional needs of vulnerable infants during critical developmental periods.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy mothers with monitored pregnancies who plan to exclusively breastfeed their newborns until four months.

Not a fit: Patients who may not benefit from this study include those with newborns having congenital malformations or other serious health conditions, as well as mothers with a history of pathological pregnancies or those who cannot commit to exclusive breastfeeding.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of human milk's nutritional components, potentially leading to improved feeding strategies for low birthweight and preterm infants.

How similar studies have performed: While studies on the human milk proteome are limited, the approach of analyzing minor proteins and peptides in human milk has shown promise in other research, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Healthy mothers
* With monitored pregnancies within the care area of the Reina Sofía University Hospital in Córdoba
* With newborns expected to be exclusively breastfed until 4 months

Exclusion Criteria:

* Mothers whose newborns have any of the following conditions: congenital malformation, chromosomal abnormality, hypoxia-ischemia, gastroschisis, polycythemia, hypoglycemia, sepsis, blood incompatibility
* Pathological pregnancy, pregnancy by in vitro fertilization, or multiple pregnancies
* With no plan to exclusively breastfeed until 4 months
* Under medical treatment
* Have a drug addiction
* Refuse informed consent
* Have had previous breast surgery
* Live outside the metropolitan area

Where this trial is running

Córdoba, Córdoba and 1 other locations

• Hospital Universitario Reina Sofía — Córdoba, Córdoba, Spain (RECRUITING)
• Maimonides Biomedical Research Institute of Cordoba (IMIBIC) — Córdoba, Córdoba, Spain (RECRUITING)

Study contacts

• Principal investigator: José Luis Gómez-Chaparro Moreno, MD, Ph.D — Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
• Study coordinator: José Luis Gómez-Chaparro Moreno, MD, Ph.D

Conditions: Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms, low birth weight, prematurity, gestational age, human milk, bioactive peptides