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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Other: Collection of breast milk

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucile LESAGE; Phone Number: 33 0491386817; Email: Lucile.LESAGE@ap-hm.fr

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hopital de La Timone
    • Contact: Aurélie Morand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastfeeding mother; Breastfeeding mother with infants between 1 and 89 days of age who presented with suspected neonatal bacterial sepsis due to the presence of a fever.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, Assistance Publique des Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Anticipated): July 12, 2024
• Study Completion (Anticipated): December 12, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: 2021-11; ID-RCB (Other Identifier: 2023-A01937-38)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No