Analyzing proteins and peptides in human milk across different breastfeeding stages
Official title: 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
Run by Maimónides Biomedical Research Institute of Córdoba · NCT06787963 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Days to 120 Days |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba Academic / other |
| Locations | 2 sites (Córdoba, Córdoba and 1 other locations) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | January 2026 |
| Study ends | December 2027 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT06787963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy mothers with monitored pregnancies who plan to exclusively breastfeed their newborns until four months.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: drgomezchaparro@gmail.com
- Phone: +34957736467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.