Genetic sequencing of bacteria in breast milk
Official title: Metagenomic Analysis of Bacterial Microbiota in Breast Milk
Run by Centre Hospitalier Sud Francilien · NCT06037421 · Data updated 2026-11-12
Researchers will use genomic sequencing to see if bacteria in breast milk given to premature newborns carry virulence genes and whether those genes are turned on.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Hour and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Centre Hospitalier Sud Francilien Academic / other |
| Locations | 1 site (Corbeil-Essonnes, France) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06037421 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women of legal age who gave birth and whose newborns are receiving care in the CHSF Neonatal Medicine and Intensive Care Unit, who intend to provide breast milk and whose parents consent, and who have not received systemic antibiotics in the three months before delivery (aside from intrapartum prophylaxis).
✕Probably not a fit
Mothers who received systemic antibiotics within three months before delivery (other than intrapartum prophylaxis) and mother–infant pairs not in the CHSF NICU are unlikely to be eligible or provide data relevant to this study and therefore may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects breast milk, saddle (nipple area), skin, saliva, and blood samples from mothers whose infants are cared for in the CHSF neonatal intensive care unit to profile bacterial communities. Samples will undergo culture to quantify Total Aerobic Flora and identify common enterobacterales and Staphylococcus aureus, while shotgun metagenomic sequencing will determine species, strain relationships, and the presence of virulence genes. The team will also examine whether identified virulence genes are expressed or repressed and compare milk strains with strains responsible for neonatal infections. Results are intended to clarify whether bacterial loads or specific strains in milk represent an infectious risk for premature infants.
Why it matters
Potential benefit: If successful, the research could help identify milk-associated infection risks and inform safer milk-handling, screening, and feeding decisions for premature infants.
How similar studies have gone: Previous studies have used metagenomic sequencing to describe breast milk microbiota, but directly linking expressed virulence genes in milk bacteria to neonatal infection risk is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women of legal age who have given birth at the CHSF (or in another establishment) and whose newborn(s) are being cared for in the CHSF's Neonatal Medicine and Intensive Care Unit, * Women wishing to give their milk to their child, * Parents who have given their consent for the mother-child couple to take part in the study. Exclusion Criteria: * Mother having received antibiotic therapy in the 3 months prior to delivery, except for those who received injectable antibiotic prophylaxis during delivery.
Where it's running
-
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, France Recruiting
Study contacts
- Study coordinator: Didier LECOINTE, PharmD
- Email: didier.lecointe@chsf.fr
- Phone: 33 1 61 69 76 69
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.