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The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections

RecruitingNAAges 18 Years - 50 YearsFemaleFundación Pública Andaluza para la Investigación …
NCT06833554 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Omega-3 Fatty Acids (EPA plus DHA)
  • Placebo
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Where

1 site
IBIMA-Plataforma Bionand
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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