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Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.

NCT05490498 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-08-05

No results posted yet for this study

Summary

Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic.

Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments.

However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).

Conditions

  • Neonatal Sepsis

Interventions

OTHER

Collection of breast milk

Collection of breast milk through a sterilized breastfeeding device. Once the collection is completed, the milk will be transferred to a sterile jar provided in a dedicated survey package for transport to the laboratory.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2024-07-12
Completion
2024-12-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490498 on ClinicalTrials.gov