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NCT05813184: PAIGAN 1
Prenatal Antibiotics and Breast Milk / Neonatal IgA
trial testing Antibiotics in Prenatal Exposure Delayed Effects in 82 participants. Currently enrolling.
30 April 2025
Quick facts
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 82 |
| Start date | 8 October 2023 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Antibiotics — full drug profile →
Conditions studied
- Prenatal Exposure Delayed Effects — all drugs for Prenatal Exposure Delayed Effects →
- Antibiotic Prophylaxis — all drugs for Antibiotic Prophylaxis →
- Dysbiosis — all drugs for Dysbiosis →
- Neonatal Infection — all drugs for Neonatal Infection →
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Who can join
Adults 18 to 40, female only, with Prenatal Exposure Delayed Effects or Antibiotic Prophylaxis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of prenatal antibiotics on breast milk and neonatal IgA and microbiome: a case-control translational study protocol.
Pietrasanta C, Ronchi A, Carlosama C, Lizier M, et al · · 2025 · cited 1× · PMID 39966546 · DOI 10.1038/s41390-025-03922-4
Verify or expand the search:
- PubMed search for NCT05813184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05813184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Last refreshed: 26 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05813184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing