Actively Recruiting
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections
Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2025-02-18
80
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project aims at identifying variations in breast milk neutrophils among lactating mothers with gestational diabetes or obesity (objective 1), and to describe how a dietary intervention with Omega-3 fatty acids affects these changes (objective 2). The occurrence of respiratory infections on the progeny will be analysed, as well as its development and the impact on gut microbiota and epigenetic changes (objective 3). The involvement of breast milk on the neonate's microbiota (sub-objective 1) and epigenetic variations (sub-objective 2) will be depicted. In addition, the direct engagement of milk neutrophils in the ability of the progeny to react against lung infections will be studied (sub-objective 3). To attain these mother milk and blood samples will be obtained from three groups of lactating mothers: control, obesity or gestational diabetes, upon a dietary intervention with Omega-3 fatty acids. Neutrophil populations of maternal blood and milk samples will be studied by flow cytometry and in vitro assays. The microbiome and miRNA content of infant's saliva and tool samples will be characterized by 16s rRNA gene sequencing and PCR. The occurrence of respiratory infections and the development the infants participating in the study will be tracked during the first 2 years of life by telephone surveys. To study the impact of the presented maternal variables on the progeny upon a respiratory inflammation on a systemic level, mouse models will be employed. The offspring of lactating dams with gestational diabetes or obesity will be subjected to an artificial acute lung infection. The progression of the lung disease will be studied by histology and the neutrophil profile in the organs of the litter by flow cytometry. The response to acute lung injury after fecal transplantation with infant's microbiota intro germ-free mice as well as of wild type pups breastfeed by neutropenic dams will complement the animal studies.
CONDITIONS
Official Title
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Full term pregnancy (greater than 37 weeks)
- Mother aged between 18 and 50 years
- Intention to exclusively breastfeed for at least 3 months
You will not qualify if you...
- Preterm pregnancy (less than 37 weeks)
- Multiple delivery
- Delivery complications that affect the newborn's well-being
- Congenital abnormalities in the baby
- Maternal health issues such as hypertension, HELLP syndrome, thyroid problems, or kidney disease
- History of drug or alcohol abuse
- Occurrence of mastitis during the study
- Mothers practicing tandem nursing
AI-Screening
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Trial Site Locations
Total: 1 location
1
IBIMA-Plataforma Bionand
Málaga, Malaga, Spain, 29590
Actively Recruiting
Research Team
A
Almudena Ortega-Gomez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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