About this trial
In this biological study, the investigators 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
pregnant women exposed or not exposed to antibiotics in the last trimester of pregnancy
Trial design
Case-control
Prospective
Treatments tested in this trial
Antibiotics
DrugAny antibiotic therapy administered \> 7 days
Treatment groups
Trial outcomes
Primary outcomes
breast milk IgA
concentration of IgA in breast milk
Secondary outcomes
fecal IgA
concentration of IgA in neonatal feces
breast milk microbiota
Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA
fecal microbiota
Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA
maternal CCL28
concentration of CCL28 in maternal serum and breast milk
Sponsors and contacts
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
Humanitas Hospital, Italy
Collaborator