Actively Recruiting

Age: 0Days - 120Days
All Genders
Healthy Volunteers
ID06787963

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

Age: 0Days - 120Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sample Collection

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

Diagnostic Evaluation

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

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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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