NCT05813184

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: —

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

Detailed description

In a human cohort of women and their neonates, the investigators 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, the investigators 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, the investigators 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.

Conditions

• Prenatal Exposure Delayed Effects
• Antibiotic Prophylaxis
• Dysbiosis
• Neonatal Infection
• Breast Milk; Noxious Influence, Affecting Fetus

Interventions

Type	Name	Description
DRUG	Antibiotics	Any antibiotic therapy administered \> 7 days

Timeline

• Start date: 2023-10-08
• Primary completion: 2025-04-30
• Completion: 2025-10-30
• First posted: 2023-04-14
• Last updated: 2024-06-26

Locations

1 site across 1 country: Italy