RecruitingOBSERVATIONAL

Improving Nutrition for Babies Born by Caesarean Section

This research wants to create a new baby formula specifically for infants born via C-section. Around 1 in 5 babies in France are born this way, and they might miss out on important good bacteria usually passed on during a vaginal birth. This can affect their health later in life. The study plans to find helpful bacteria from breast milk and babies' poo, and then add these, along with special fats found in breast milk, to a new formula. The goal is to help C-section babies get a healthier start, improving their gut health and potentially lowering their risk of certain long-term health issues. The formula will be tested to make sure it's helpful and safe.

At a glance

Status

Recruiting

Sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Enrolment target

Start

30 Sep 2025

Estimated completion

30 Sep 2028

Breastfeeding Mothers of Legal Age Their Babies Under 6 Months Old Born Vaginally

What is this study about?

When babies are born, especially during a vaginal delivery, they usually pick up lots of good bacteria from their mother. This helps their gut develop and teaches their body to fight off illnesses. However, babies born by C-section sometimes miss out on this early transfer of helpful bacteria. This can lead to a different mix of bacteria in their gut, which some research suggests might be linked to health problems later on in life.

Currently, there isn't a special baby formula designed just for C-section babies to address this particular issue. While breastfeeding helps, and is always encouraged, some mothers find it difficult, especially after a C-section. This study wants to fill that gap. Researchers are looking closely at breast milk and the poo of healthy breastfed babies born naturally to find the best types of good bacteria. They also want to add important fats, similar to those found in breast milk, that are often missing from regular formulas.

The main aim is to develop a new and improved baby formula. This formula would include carefully selected good bacteria and special fats, all designed to help C-section babies build a healthy gut from the very beginning. The hope is that by changing their early nutrition, these babies will have a better start and potentially face fewer health challenges as they grow up.

Key takeaways

This study aims to improve the health of C-section babies.
It's developing a new baby formula with helpful bacteria and fats.
The goal is to boost natural gut development.
Currently looking for healthy, breastfed mothers and vaginally born babies for samples.
Participation involves providing breast milk and baby stool samples.

Who may be eligible?

This study is looking for healthy breastfeeding mothers and their healthy babies who were born vaginally. Mothers need to be 18 years or older, have been breastfeeding for less than six months, and haven't taken antibiotics or probiotics recently. They also need to be generally healthy, without certain medical conditions or a high BMI before pregnancy.

Their babies must be under six months old, have been born vaginally and at full-term (at least 37 weeks), and be exclusively breastfed. The babies shouldn't have any known health problems or be taking any medical supplements other than standard vitamins. This is because the study needs to collect breast milk and baby poo samples from healthy mothers and babies who had a natural start, to help develop the new formula.

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 breastfeeding mother aged 18 or over?
Has your baby been born naturally (vaginally)?
Is your baby less than 6 months old and exclusively breastfed?
Have neither you nor your baby taken antibiotics or probiotics recently?
Are you both generally healthy with no ongoing medical conditions?

Answer every question to see your result.

What does participation involve?

This part of the study involves collecting samples from healthy breastfeeding mothers and their babies. If you fit the criteria, you would be asked to provide samples of your breast milk. Your baby would also be asked to provide stool (poo) samples. The study will explain exactly how to collect these samples at home. There are no interventions or medications given to participants in this phase. The overall duration for mothers and babies giving samples would be short, focusing on collecting the necessary information for the researchers.

Potential risks and benefits

This study does not involve giving any experimental treatments to participants. The potential benefit for those taking part is contributing to research that could greatly improve the health of babies born by C-section in the future. The risks are very low, mainly involving the minor inconvenience of collecting breast milk and baby stool samples. You would be fully informed about the process and have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

INRAE
Verified postcode
Jouy-en-Josas, France· Recruiting

Common questions

What is the main goal of this study?

To create a special baby formula for babies born by C-section to help their gut develop healthily.

Why is this formula needed for C-section babies?

C-section babies might miss out on important good bacteria during birth, which can affect their long-term health.

What will the special formula contain?

Beneficial bacteria found in breast milk and baby poo, plus special fats similar to those in breast milk.

Who can take part in this research?

Healthy breastfeeding mothers (18+) and their healthy, exclusively breastfed babies (under 6 months) who were born vaginally.

What will I need to do if I take part?

You'll provide samples of your breast milk, and your baby will provide stool samples.

How to find out more

REBECA MARTIN-ROSIQUE, PhD

rebeca.martin-rosique@inrae.fr 00 33 1 34 65 20 98 Official trial record

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