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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
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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