Effects of prenatal antibiotics on breast milk and neonatal immune response
Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA
This study is testing how taking antibiotics during pregnancy affects the immune system of newborns by looking at the levels of a specific antibody in breast milk and baby poop.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05813184 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of prenatal antibiotic exposure on the levels of immunoglobulin A (IgA) in breast milk and neonatal feces. It involves a cohort of mother-infant pairs, with one group receiving antibiotics during the last trimester of pregnancy and a control group not receiving any antibiotics. The study will analyze breast milk and fecal samples at multiple time points during the first year of life to assess microbiota composition and IgA levels. The goal is to understand how prenatal antibiotic treatment influences neonatal immune development through breast milk.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who plan to breastfeed and have either received or not received antibiotics for at least 7 days after 32 weeks of gestation.
Not a fit: Patients who intend to exclusively formula feed or have significant concerns about breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing maternal antibiotic use during pregnancy to enhance neonatal immune health.
How similar studies have performed: While there have been studies on the effects of antibiotics on microbiota, this specific approach focusing on IgA levels and breastfeeding is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Pietrasanta, MD,PhD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study coordinator: Carlo Pietrasanta, MD,PhD
- Email: carlo.pietrasanta@unimi.it
- Phone: +393337505802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.