Metagenomic Analysis of Bacterial Microbiota in Breast Milk

NCT06037421 | Recruiting

• 1 other identifier: 2023-A01731-44
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the extent to which bacteria in the breast milk microbiota represent an infectious risk for premature infants, by investigating whether they possess virulence genes, and if so, whether these are expressed or repressed.

Conditions

Bacteria in Breast Milk

Keywords

Bacterial; newborn breast milk; neonates; infectious risk; virulence genes; agar culture methods; shotgun metagenomics; targeted metagenomics; microbiota

Outcome Measures

Primary Outcomes (1)

• Assessing the potential pathogenic risk of certain bacteria in breast milk.

  Presence of virulence genes in strains of bacteria with pathogenic potential (S. aureus, K. aerogenes, E. coli, K. pneumoniae, K. oxytoca, E. cloacae) in breast milk.

  at day 0

Other Outcomes (6)

• Comparing the microbial ecologies of breast milk by bacterial culture and metagenomics.

  at day 0

• If bacteria isolated from breast milk contain virulence genes, establish whether they are activated or repressed.

  at day 0

• Establish whether strains of bacteria with pathogenic potential (S. aureus, K. aerogenes, E. coli, K. pneumoniae, K. oxytoca, E. cloacae) found in breast milk contain antibiotic resistance genes.

  at day 0

Interventions

Saddle sampling OTHER

Saddle sampling

Skin sampling OTHER

Skin sampling

Saliva sampling OTHER

Saliva sampling

Human breast milk sampling OTHER

Human breast milk sampling

blood sampling OTHER

blood sampling

Eligibility Criteria

• Age: 1 Hour+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mother-infant pairs whose newborn(s) are being cared for in the CHSF's Neonatal Medicine and Intensive Care Unit.

You may qualify if:

• 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.

You may not qualify if:

• Mother having received antibiotic therapy in the 3 months prior to delivery, except for those who received injectable antibiotic prophylaxis during delivery.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human breast milk samples, mother's stool samples, infant's stool samples, mother's saliva samples, infant's saliva samples, mother's skin samples, mother's blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Didier LECOINTE, PharmD

CONTACT

33 1 61 69 76 69; didier.lecointe@chsf.fr

Caroline TOURTE

CONTACT

33 1 61 69 31 50; caroline.tourte@chsf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 14, 2023
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)