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

NCT06833554 | Recruiting

• 1 other identifier: PI22/01813
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (2)

• Characterization of milk neutrophils from three groups of lactating mothers: control or gestational diabetes.

  From enrollment to end of treatment at 3 months

• Characterization of microbiota and miRNA content of breast milk

  From enrollment to end of treatment at 3 months

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Omega-3 Fatty Acids (EPA plus DHA) DIETARY_SUPPLEMENT

Dietary supplementation with Omega-3 Fatty Acids to study the effect on the immune system of breast milk

Omega-3

Placebo DIETARY_SUPPLEMENT

Inert dietary supplement, without activity in the activation of the immune system of breast milk

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only female participants are eligible as the study is focused on lactation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• full term pregnancy (\>37 weeks)
• mother age 18-50 years
• intention to practice exclusive breastfeeding for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

IBIMA-Plataforma Bionand

Málaga, Malaga, 29590, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Almudena Ortega-Gomez

CONTACT

+34 952367600; almudena.ortega@ibima.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: January 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

ES (1)