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Search / Trial NCT05813184

Prenatal Antibiotics and Breast Milk / Neonatal IgA

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Apr 2, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ig A Prenatal Antibiotics Breast Milk Feces Neonatal Immune System

ClinConnect Summary

This clinical trial is studying how prenatal antibiotics, taken by mothers during pregnancy, affect important components in breast milk and the gut bacteria of newborns in their first year of life. Specifically, the researchers want to see how these antibiotics impact the levels of a protective substance called IgA in both breast milk and the baby's stool. They are looking for mothers who have taken antibiotics for at least 7 days after their 32nd week of pregnancy, as well as a control group of mothers who did not take any antibiotics during pregnancy.

To participate, mothers need to be willing to breastfeed their babies for as long as possible during the first year and must provide written consent. However, those who plan to exclusively formula feed or have certain health issues may not be eligible. Participants can expect to provide samples of their breast milk and their baby’s stool over the course of the study, which will help researchers understand the long-term effects of prenatal antibiotics on infant health. This study is currently recruiting participants, and it aims to gather valuable information that could improve care for newborns and breastfeeding mothers.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • expression of written informed consent
  • an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)
  • the intention to breastfeed their neonates as long as possible during the first year of life
  • Exclusion Criteria:
  • absence of written informed consent
  • the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)
  • a maternal antibiotic treatment shorter than 7 days
  • the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)
  • a delivery at a gestational age \< 34 weeks
  • the administration of antibiotics to neonates after birth, within the first week of life.

About Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is a prestigious research and clinical care institution based in Milan, Italy. Renowned for its commitment to advancing medical knowledge and improving patient outcomes, the foundation integrates cutting-edge research with high-quality healthcare services. It serves as a hub for innovative clinical trials, fostering collaborations among healthcare professionals, researchers, and academic institutions. With a focus on various therapeutic areas, the foundation aims to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Carlo Pietrasanta, MD,PhD

Principal Investigator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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