Actively Recruiting
Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-06-26
82
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
H
Humanitas Hospital, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how prenatal antibiotic use affects immune factors and gut bacteria in breast milk and newborns during the first year of life. The study compares mothers who took antibiotics for at least 7 days after 32 weeks of pregnancy with those who did not, focusing on immune protein IgA and microbiota composition. The goal is to understand how these factors develop in breast milk and infant feces and how maternal immune pathways might influence this process. The study involves two groups: mothers treated with antibiotics during late pregnancy and mothers who were not. Researchers will collect and analyze breast milk, maternal serum, and infant feces samples at multiple times: within the first week after birth, at 1 month, 3 months, and between 8 to 12 months or until breastfeeding stops. Techniques include measuring IgA levels, studying bacteria coated or not coated with IgA, and assessing a chemokine marker related to immune cell migration. Participants will provide samples at each time point while exclusively breastfeeding. The study measures breast milk IgA as the main outcome, along with fecal IgA, microbiota composition in milk and feces, and maternal CCL28 levels. These assessments help track immune development in infants exposed or not exposed to prenatal antibiotics. The study is expected to last up to 12 months of neonatal life with repeated detailed immune and microbiota evaluations.
CONDITIONS
Brief Title
Prenatal Antibiotics and Breast Milk / Neonatal IgA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expression of written informed consent
- Antibiotic treatment for at least 7 consecutive days after 32 weeks of pregnancy or no antibiotic exposure during pregnancy for control group
- Intention to breastfeed neonates exclusively as long as possible during the first year of life
You will not qualify if you...
- Absence of written informed consent
- Intention to exclusively formula feed or significant maternal concerns about breastfeeding
- Maternal antibiotic treatment shorter than 7 days
- Presence of pre-existing maternal immune-mediated disorders including immunodeficiencies and chronic infectious diseases
- Delivery before 34 weeks of gestational age
- Administration of antibiotics to neonates within the first week after birth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months of neonatal life
Participants are observed to collect breast milk, maternal serum, and neonatal feces samples at specified timepoints to evaluate immune function and microbiota composition.
4 visits during the first week, at 1 month, 3 months, and between 8 to 12 months of neonatal life
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
Research Team
C
Carlo Pietrasanta, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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