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

Neonatal Sepsis Clinical Trial

— MINEOS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490498
• Other study ID #: 2021-11
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: December 12, 2024

Study information

• Verified date: August 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Lucile LESAGE
• Phone: 0491386817
• Email: Lucile.LESAGE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 12, 2024
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Breastfeeding mothers of infants:

• Aged 1 to 89 days consulting in hospitals in the Marseille area (Assistance Publique des Hôpitaux de Marseille: Hôpital de la Timone-enfants and Hôpital Nord),

• Suspected neonatal bacterial infection due to the presence of fever (rectal or axillary temperature > 38°C),

• In whom bacteriological samples have been taken (cerebrospinal fluid, joint fluid, blood cultures, urine),

• Patients affiliated or benefiting from a social security system.

Exclusion Criteria:

• Exclusive formula milk feeding

• Opposition of legal guardians

• No bacteriological sample to prove infant infection

• No confirmation of fever by standardized method

• Opposition to participating in the study

• Neonatal hospitalization > 48 hours for management of prematurity.

• Severe congenital malformations in the infant.

• Antibiotic treatment for a concomitant bacterial infection in the infant.

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
France	Hopital de la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of bacterial carriage of breast milk	Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.	18 months
Secondary	Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.	Compare the bacterial carriage (type of germs found) of the breast milk of infants with neonatal sepsis to breast milk of infants with fever for another cause (virus, non identified germ)	18 months
Secondary	Comparison of milk germs to children's germs.	Compare the germs found in the breast milk of each mother-infant pair with a bacterial infection with the germs identified in the infant.	18 months
Secondary	Comparison of microbiota profiles in breast milk	Compare the bacterial composition of the breast milk of mother-infant pairs with the same germ (germ infecting the child identical to the germ identified in the mother's milk) versus mother-infant pairs with a different germ in the milk (no germ found in the child when a germ was identified in the breast milk, or germ infecting the child different from the germ identified in the mother's milk).	18 months