Back to resultsStudy of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age. (MINEOS)
Primary Purpose
Neonatal Sepsis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of breast milk
Sponsored by
About this trial
This is an interventional other trial for Neonatal Sepsis
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.
Sites / Locations
- Hopital de la TimoneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breastfeeding mother
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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.
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).
Full Information
NCT ID
NCT05490498
First Posted
August 3, 2022
Last Updated
August 3, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT05490498
Brief Title
Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
July 12, 2024 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breastfeeding mother
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of breast milk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of bacterial carriage of breast milk
Description
Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.
Description
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)
Time Frame
18 months
Title
Comparison of milk germs to children's germs.
Description
Compare the germs found in the breast milk of each mother-infant pair with a bacterial infection with the germs identified in the infant.
Time Frame
18 months
Title
Comparison of microbiota profiles in breast milk
Description
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).
Time Frame
18 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breastfeeding mothers
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucile LESAGE
Phone
0491386817
Ext
33
Email
Lucile.LESAGE@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Hopital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Morand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.
We'll reach out to this number within 24 hrs