The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Fatty Acids (EPA plus DHA), Placebo.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus (GDM). Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases and Impact on Infant Development and Response to Pulmonary Infections
Overview
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.
Interventions
- Dietary supplement 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 - Dietary supplement Placebo
Inert dietary supplement, without activity in the activation of the immune system of breast milk
Primary outcome measures
- Characterization of milk neutrophils from three groups of lactating mothers: control or gestational diabetes. [Time frame: From enrollment to end of treatment at 3 months]
- Characterization of microbiota and miRNA content of breast milk [Time frame: From enrollment to end of treatment at 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- IBIMA-Plataforma Bionand — Málaga
Identifiers
NCT: NCT06833554 · PI22/01813