Prenatal Antibiotics and Breast Milk / Neonatal IgA (NCT05813184) | Clinical Trial Compass
RecruitingNot Applicable
Prenatal Antibiotics and Breast Milk / Neonatal IgA
Italy82 participantsStarted 2023-10-08
Plain-language 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
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
breast milk IgA
Timeframe: until 12 months of neonatal life
Trial details
NCT IDNCT05813184
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico