Investigating the effects of breast milk from mothers with metabolic diseases on infant health after dietary changes
Official title: The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases and Impact on Infant Development and Response to Pulmonary Infections
Run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · NCT06833554 · Data updated 2026-11-12
This study is testing how changes in the diet of mothers with gestational diabetes or obesity affect the breast milk they produce and whether that impacts their infants' health, particularly regarding infections and development.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Malaga) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | July 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT06833554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are lactating mothers aged 18-50 with full-term pregnancies who intend to exclusively breastfeed for at least three months.
✕Probably not a fit
Patients who have preterm pregnancies, multiple deliveries, or significant maternal health complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to analyze variations in breast milk neutrophils from lactating mothers with gestational diabetes or obesity and how a dietary intervention with Omega-3 fatty acids influences these changes. The study will evaluate the incidence of respiratory infections in infants, their development, and the impact on gut microbiota and epigenetic modifications. Blood and milk samples will be collected from three groups of mothers: control, obesity, and gestational diabetes, to study neutrophil populations using flow cytometry. The research seeks to understand the role of breast milk in neonatal microbiota and immune response to lung infections.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how maternal nutrition impacts infant health and immune responses.
How similar studies have gone: While there is ongoing research into maternal nutrition and infant health, this specific approach focusing on neutrophils and dietary intervention is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * full term pregnancy (\>37 weeks) * mother age 18-50 years * intention to practice exclusive breastfeeding for at least 3 months Exclusion Criteria: * preterm pregnancy (\<37 weeks) * multiple delivery * delivery complications that compromise the well-being of the newborn * congenital abnormalities of the baby * pathologies of the mother such as hypertension, HELLP syndrome, thyroids alterations or nephropathies - drugs or alcohol abuse record * occurrence of mastitis during the study * mothers practicing tandem nursing
Where it's running
-
IBIMA-Plataforma Bionand
Málaga, Malaga, Spain Recruiting
Study contacts
- Study coordinator: Almudena Ortega-Gomez
- Email: almudena.ortega@ibima.eu
- Phone: +34 952367600
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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.