The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections
NCT ID: NCT06833554
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Omega-3
Omega-3 Fatty Acids (EPA plus DHA)
Dietary supplementation with Omega-3 Fatty Acids to study the effect on the immune system of breast milk
Placebo
Placebo
Inert dietary supplement, without activity in the activation of the immune system of breast milk
Interventions
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Omega-3 Fatty Acids (EPA plus DHA)
Dietary supplementation with Omega-3 Fatty Acids to study the effect on the immune system of breast milk
Placebo
Inert dietary supplement, without activity in the activation of the immune system of breast milk
Eligibility Criteria
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Inclusion Criteria
* mother age 18-50 years
* intention to practice exclusive breastfeeding for at least 3 months
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
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Locations
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IBIMA-Plataforma Bionand
Málaga, Malaga, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PI22/01813
Identifier Type: -
Identifier Source: org_study_id
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