NCT05490498

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

Exploration of Breast Milk by Culture Through "Microbial Culturomics" and by Targeted Metagenomics Through 16S Ribosomal RNA Gene Sequencing. Influence on the Development of Early and Late Neonatal Sepsis in Infants Under Three Months of Age.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-07-12
• Completion: 2024-12-12
• First posted: 2022-08-05
• Last updated: 2022-08-05

Locations

1 site across 1 country: France