Investigating the effects of breast milk from mothers with metabolic diseases on infant health after dietary changes
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases and Impact on Infant Development and Response to Pulmonary Infections
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Malaga) |
| Trial ID | NCT06833554 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are lactating mothers aged 18-50 with full-term pregnancies who intend to exclusively breastfeed for at least three months.
Not a fit: Patients who have preterm pregnancies, multiple deliveries, or significant maternal health complications may not benefit from this study.
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 performed: While there is ongoing research into maternal nutrition and infant health, this specific approach focusing on neutrophils and dietary intervention is relatively novel.
Eligibility criteria
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 this trial is running
Málaga, Malaga
- IBIMA-Plataforma Bionand — Málaga, Malaga, Spain (Recruiting)
Study contacts
- Study coordinator: Almudena Ortega-Gomez
- Email: almudena.ortega@ibima.eu
- Phone: +34 952367600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.