RecruitingNCT05813184

Prenatal Antibiotics and Breast Milk / Neonatal IgA

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


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

82 participants

Start Date

Oct 8, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DRUGAntibiotics

Any antibiotic therapy administered \> 7 days


Locations(1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

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NCT05813184


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