RecruitingOBSERVATIONAL

Metagenomic Analysis of Bacterial Microbiota in Breast Milk

This research aims to understand the bacteria found in breast milk. Scientists want to know how much of a risk these bacteria might pose to premature babies, especially regarding infections. They will investigate if some bacteria carry genes that could make them harmful and whether these genes are active. We know breast milk is very important, but we don't fully understand all the bacteria it contains. The study will compare different ways of testing breast milk to get a clearer picture of its bacterial make-up. This will help understand if certain bacteria are truly a concern for newborn infections or if they are usually harmless. The long-term goal is to make sure breast milk is as safe and beneficial as possible for vulnerable babies.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Sud Francilien

Enrolment target

120

Start

08 Sep 2025

Estimated completion

31 Dec 2028

Bacteria in Breast Milk

What is this study about?

Imagine breast milk as a tiny, living world filled with many microscopic organisms, including bacteria. Most of these bacteria are helpful or harmless, but sometimes, certain types could potentially cause problems. This study is like a detective story trying to understand which bacteria live in breast milk, what their jobs are, and if any of them could be linked to infections in very delicate premature babies.

At the moment, we don't have a full map of all the bacteria in breast milk. We also don't completely understand if a certain amount of a particular bacteria is always a warning sign. Current ways of testing breast milk for bacteria aren't always standard, making it tricky to get a clear picture across different hospitals. This study uses advanced genetic testing, called 'metagenomic sequencing,' which is like reading the DNA blueprint of all the bacteria in the milk. This allows researchers to get a much more detailed and accurate list of what's there.

By carefully comparing the bacteria found in breast milk with those that sometimes cause infections in newborns, the researchers hope to learn if they are the same types. This could help doctors understand if giving a baby breast milk with certain bacteria is truly risky or if it's generally safe. Ultimately, this research aims to give us a much better understanding of breast milk's bacterial make-up, so we can ensure the safest and best nutrition for premature babies.

Key takeaways

Researchers are studying bacteria in breast milk.
The aim is to understand if these bacteria are always safe for premature babies.
Advanced DNA testing will be used to identify bacteria.
No new treatments or medications are involved, only sample collection.
Results could help improve care for future premature babies.

Who may be eligible?

To join this study, you need to be a mother who has recently given birth at the CHSF hospital (or another hospital if your baby is now at CHSF's neonatal unit) and whose baby is being cared for in their special care unit for newborns.

You should also be planning to feed your baby with your own breast milk. You and your baby's other parent will need to agree and give your permission for both you and your baby to take part in the study.

You cannot join the study if you have taken antibiotics in the three months before your baby was born, unless it was a short-term antibiotic given during your labour to prevent infection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a mother whose baby is in the special care unit at CHSF?
Are you planning to give your own breast milk to your baby?
Have you *not* taken antibiotics in the last 3 months (unless it was for labour)?
Are you able to provide consent for yourself and your baby to participate?

Answer every question to see your result.

What does participation involve?

The study involves collecting different types of samples from you. This includes samples of your breast milk, and samples from your skin, saliva, and blood. There will also be some sampling involved for your baby, such as a tiny sample from their skin. The researchers will be looking at these samples to identify the types of bacteria present. The detailed plan for when and how often these samples will be taken is not specified in the summary, but it would typically happen over a set period. There are no medications or treatments involved as part of this study, it's purely for observation and analysis. The total length of your and your baby's participation would be explained fully by the study team.

Potential risks and benefits

Participating in this study might not directly benefit you or your baby, but the information gained will help future premature babies by providing a better understanding of breast milk and infection risks. Potential risks are generally low, mainly involving the discomfort of sample collection like a blood draw or skin swab. You are free to withdraw from the study at any time without giving a reason, and this decision will not affect your or your baby’s care.

Locations (1)

Centre Hospitalier Sud Francilien
Verified postcode
Corbeil-Essonnes, France· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand the bacteria in breast milk and if they pose any infection risk to premature babies.

Will my baby or I receive any new treatments in this study?

No, this is an observational study. It involves collecting samples, not giving new treatments or medications.

What kind of samples will be collected?

The study will collect samples of your breast milk, skin, saliva, and blood, and some skin samples from your baby.

Who can join this study?

Mothers whose babies are in the neonatal unit at CHSF and who plan to breastfeed are invited, provided they meet other criteria.

If I join, can I change my mind later?

Yes, you can leave the study at any time without it affecting your or your baby's medical care.

How to find out more

Didier LECOINTE, PharmD

didier.lecointe@chsf.fr 33 1 61 69 76 69 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.