The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections (PI2222/01813)

February 17, 2025 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Malaga
      • Málaga, Malaga, Spain, 29590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Inert dietary supplement, without activity in the activation of the immune system of breast milk
Active Comparator: Omega-3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
From enrollment to end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI22/01813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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