Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Sepsis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Description of bacterial carriage of breast milk
timeFrame: 18 months
Secondary outcomes:
measure: Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.
timeFrame: 18 months
measure: Comparison of milk germs to children's germs.
timeFrame: 18 months
measure: Comparison of microbiota profiles in breast milk
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital de la Timone
Study officials:
affiliation: ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
name: François CREMIEUX
role: STUDY_DIRECTOR
References: