Actively Recruiting
Quantitative Proteomic Analysis of Minor Whey Proteins and Peptides in Human Milk Across Five Neonatal Birth Weight Groups During Three Lactation Stages
Led by Maimónides Biomedical Research Institute of Córdoba · Updated on 2025-01-22
150
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
Sponsors
M
Maimónides Biomedical Research Institute of Córdoba
Lead Sponsor
H
Hospital Universitario Reina Sofia de Cordoba
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the minor proteins and peptides found in human milk to understand their roles in newborn nutrition, growth, and development. This observational study focuses on how these components vary across five groups of breastfeeding mothers categorized by their newborns' birth weights, ranging from extremely low to high birth weight. The research aims to expand knowledge about the bioactive functions of proteins in human milk during different lactation stages and how these may influence neonatal health. Human milk samples will be collected from each mother during three time periods: within the first 48 hours after birth (colostrum), between 5 and 14 days (transitional milk), and between 100 and 120 days (mature milk). The study includes groups of mothers with newborns classified by birth weight: extremely low, very low, low, adequate, and high. Proteomic techniques will be used to separate, quantify, and identify minor whey proteins and peptides in these samples, considering gestational age for group consistency. Participants will provide milk samples at each lactation stage, and researchers will analyze minor whey proteins such as lysozyme, lactoferrin, bile salt-dependent lipase, lactoperoxidase, and alpha-1-antitrypsin, as well as peptides mainly derived from beta-casein. Additional assessments include muscular and transfontanellar ultrasound exams at matching time points. The study will measure changes in protein and peptide profiles over time and across birth weight groups to better understand their impact on infant development. The study is expected to continue until December 2027.
CONDITIONS
Brief Title
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy mothers
- Monitored pregnancies within the care area of Reina Sofía University Hospital in Córdoba
- Newborns expected to be exclusively breastfed until 4 months
You will not qualify if you...
- Newborns with congenital malformation, chromosomal abnormality, hypoxia-ischemia, gastroschisis, polycythemia, hypoglycemia, sepsis, or blood incompatibility
- Pathological pregnancy, pregnancy by in vitro fertilization, or multiple pregnancies
- No plan to exclusively breastfeed until 4 months
- Mothers under medical treatment
- Mothers with drug addiction
- Refusal of informed consent
- Previous breast surgery
- Living outside the metropolitan area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From birth to 120 days postpartum
Participants provide human milk samples at three different lactation stages for proteomic analysis.
3 visits at 48 hours, 5-14 days, and 100-120 days postpartum
Duration - From birth to 120 days postpartum
Participants undergo muscular and transfontanellar ecography assessments at three timepoints after birth.
3 visits at 48 hours, 5-14 days, and 100-120 days postpartum
Trial Site Locations
Total: 2 locations
1
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
2
Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
Research Team
J
José Luis Gómez-Chaparro Moreno, MD, Ph.D
Á
Ángel Gil, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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