Prenatal Antibiotics and Breast Milk / Neonatal IgA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Antibiotics

    Drug

    Any antibiotic therapy administered \> 7 days

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Control0 interventions
Group B: Prenatal antibiotics1 intervention

Trial outcomes

Primary outcomes

1

breast milk IgA

concentration of IgA in breast milk

Time frame
until 12 months of neonatal life

Secondary outcomes

1

fecal IgA

concentration of IgA in neonatal feces

Time frame
until 12 months of neonatal life
2

breast milk microbiota

Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA

Time frame
until 12 months of neonatal life
3

fecal microbiota

Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA

Time frame
until 12 months of neonatal life
4

maternal CCL28

concentration of CCL28 in maternal serum and breast milk

Time frame
until 12 months of neonatal life

Other outcomes

Sponsors and contacts

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