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Metagenomic Analysis of Bacterial Microbiota in Breast Milk

NCT ID: NCT06037421

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-08

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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There are still many unknowns about the exact bacterial composition of breast milk, and the theoretical and real risks represented by its microbiota. In addition to determining the Total Aerobic Flora (TAF) and the Staphylococcus aureus presence, the most commonly isolated enterobacterales species identified by agar culture by the Prevention and Infection Control department are also among those potentially found in diagnostic samples: Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca and Escherichia coli. However, it is not yet known whether these are identical strains or not. It is therefore legitimate to ask whether there are any differences between the strains present in the microbiota of breast milk and those responsible for newborn infections.

Conventional methods for enumerating and identifying the bacteria making up the milk microbiota are not standardized, which makes it difficult to draw up a precise, multicentric inventory of its composition. It is therefore impossible to know whether exceeding a threshold value defined by expert consensus represents a real danger for newborns who must receive breast milk.

At the Centre National de Recherche en Génomique Humaine (CNRGH), a metagenomic sequencing approach makes it possible to study the microbiota using two complementary methodologies. Either by sequencing the genomes of organisms (bacteria, viruses, fungi, etc.) present in the environment to be analyzed (shotgun metagenomics), or by sequencing one or more genes specific to each bacterial species (targeted metagenomics). The gene that codes for 16S ribosomal RNA (rRNA) has sequence regions common to different bacterial species, as well as variable regions that can be used to distinguish the bacteria present in a sample.

A comparison of the composition of the bacterial microbiota in breast milk using conventional agar culture methods and metagenomic analysis methods would enable us to make progress in understanding its potential involvement in infectious pathologies in premature infants. It is in this scientific and medical context that a collaborative project was initiated for the first time between the departments of Neonatal Medicine and Intensive Care and of Prevention and Infection Control, and the CNRGH. This was a pilot study with the aim of perpetuating this collaboration, which combines scientific knowledge of the metagenome with the CNRGH's high-performance technological tools, as well as potential applications in the medical environment in the CHSF's care departments.

Conditions

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Bacteria in Breast Milk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Human breast milk sampling

Human breast milk sampling

Intervention Type OTHER

Saddle sampling

Saddle sampling

Intervention Type OTHER

Skin sampling

Skin sampling

Intervention Type OTHER

Saliva sampling

Saliva sampling

Intervention Type OTHER

blood sampling

blood sampling

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Didier LECOINTE, PharmD

Role: CONTACT

[email protected]
33 1 61 69 76 69

Caroline TOURTE

Role: CONTACT

[email protected]
33 1 61 69 31 50

Facility Contacts

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Didier LECOINTE, PharmD

Role: primary

[email protected]
33 1 61 69 76 69

Benjalin QUERIN, Pharmacy intern

Role: backup

[email protected]

Other Identifiers

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2023-A01731-44

Identifier Type: -

Identifier Source: org_study_id