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Prenatal Antibiotics and Breast Milk / Neonatal IgA — PAIGAN 1  

Dysbiosis Clinical Trial

Official title:
Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA

Clinical Trial Summary

In this biological study, we will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation

Clinical Trial Description

In a human cohort of women and their neonates, we aim to evaluate the absolute amount of IgA in maternal breast milk and in neonatal feces in the presence (N=41 mother/infant pairs) or in the absence (N=41 mother/infant pairs) of exposure to prenatal ABX during the last period of pregnancy. Moreover, we aim to evaluate, both in maternal breast milk and in neonatal feces, the composition of microbiota, and the proportion and composition of the IgA-coated and not-IgA- coated fractions of microbiota, by means of fluorescence-activated cell sorting (FACS) coupled with 16S rRNA sequencing of bacteria. Finally, we will measure the concentration of the chemokine CCL28 on maternal serum and breast milk, as a soluble marker of activity of the entero-mammary pathway that is known to drive the migration of IgA producing plasma- cells from maternal mesenteric lymph nodes to the mammary gland. All the analysis will be performed in mother-infant dyads with exclusive breastfeeding. Breast milk/serum/feces collection and analysis will be repeated at the following timepoints: 1. during the first week of neonatal life 2. at 1 month of life 3. at 3 months of life 4. at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05813184
Study type Observational
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Carlo Pietrasanta, MD,PhD
Phone +393337505802
Email carlo.pietrasanta@unimi.it
Status Not yet recruiting
Phase
Start date April 30, 2023
Completion date October 30, 2025
View Details
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