Neonatal SepsisMINEOSNCT05490498
Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.
A study testing Collection of breast milk in people with Neonatal Sepsis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Collection of breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital de la Timone
Marseille
Aurélie Morand
About this study
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.
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
- Being tested
- Collection of breast milk
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of breast milkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding mother | Experimental | 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. Receives: Other: Collection of breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start13 Jul 2022
- Primary completion12 Jul 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490498
- Sponsor's protocol ID
- 2021-11
- Other IDs
- ID-RCB
- Acronym
- MINEOS
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05490498
- Acronym / sponsor ID
- MINEOS / 2021-11
- Conditions
- Neonatal Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 12 Jul 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding mother | Experimental | Other: Collection of breast milkBreastfeeding mother with infants between 1 and 89 days of age who presented with suspected neonatal bacterial sepsis due to the presence of a fever. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of breast milkCollection 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. | Other | Breastfeeding mother |
Primary outcome
Description of bacterial carriage of breast milk
Time frame: 18 months
Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.
3 secondary outcomes
Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.
Time frame: 18 months
Comparison of milk germs to children's germs.
Time frame: 18 months
Comparison of microbiota profiles in breast milk
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François CREMIEUX study director
ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of breast milk in people with Neonatal Sepsis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucile LESAGE (0491386817 ext. 33, Lucile.LESAGE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of bacterial carriage of breast milk (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.