Metagenomic Analysis of Bacterial Microbiota in Breast Milk
ConditionBacteria in Breast Milk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorCentre Hospitalier Sud Francilien
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Mother having received antibiotic therapy in the 3 months prior to delivery, except for those who received injectable antibiotic prophylaxis during delivery.
Trial population
Mother-infant pairs whose newborn(s) are being cared for in the CHSF's Neonatal Medicine and Intensive Care Unit.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Human breast milk sampling
Other interventionHuman breast milk sampling
Saddle sampling
Other interventionSaddle sampling
Skin sampling
Other interventionSkin sampling
Saliva sampling
Other interventionSaliva sampling
blood sampling
Other interventionblood sampling
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
at day 0Other outcomes
1
Comparing the microbial ecologies of breast milk by bacterial culture and metagenomics.
Presence in breast milk of identical bacterial genera or species/strains between sequencing and bacterial culture.
Time frame
at day 02
If bacteria isolated from breast milk contain virulence genes, establish whether they are activated or repressed.
Production by bacteria isolated from breast milk of the mRNA and/or protein corresponding to the virulence gene(s) identified.
Time frame
at day 03
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.
Presence of antibiotic resistance genes in strains of bacteria with pathogenic potential (S. aureus, K. aerogenes, E. coli, K. pneumoniae, K. oxytoca, E. cloacae) found in breast milk.
Time frame
at day 04
If so, establish whether these are activated or repressed.
Production by bacteria isolated from breast milk of the mRNA and/or protein corresponding to the antibiotic resistance gene.
Time frame
at day 0Sponsors and contacts
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Source ClinicalTrials.gov