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Impact of Breast Milk miRNAs on the Infant Gut Microbiota

This study is about understanding how breast milk helps develop a baby's tummy health. We know the first few years of life are really important for future health, and having a healthy gut is key. Breast milk contains tiny particles called miRNAs that formula milk doesn't have. Scientists think these miRNAs might help shape the good bacteria in a baby's gut. We're comparing babies who are only breastfed with those who have formula milk to see if these miRNAs in breast milk really do change what's in a baby's poo and how their gut bacteria grow over their first year. This research could help us learn more about why breast milk is so good for babies.

At a glance

Status
Not yet recruiting
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
200
Start
01 Nov 2024
Estimated completion
31 May 2027

What is this study about?

This study aims to understand the special role breast milk plays in a baby's health, particularly in developing their gut, which is their tummy and intestines. The first 1,000 days of a baby's life are incredibly important for setting them up for good health in the future. A healthy gut, full of good bacteria, is known to help prevent both short-term illnesses and longer-term health problems. We already know that breastfed babies tend to be healthier than those fed formula.

One big difference between breast milk and formula is that breast milk contains tiny, natural substances called miRNAs. These miRNAs are thought to act like messengers, influencing how the baby's body works and how the good bacteria in their gut grow and develop. The main idea behind this study is to see if these miRNAs from breast milk actually make their way into a baby's system and change the types and amounts of bacteria found in their poo.

To find this out, researchers will be comparing babies who are exclusively breastfed with babies who are exclusively fed formula. They will be looking closely at samples of breast milk and baby poo at different times during the baby's first year. By doing this, they hope to learn more about how breast milk's unique ingredients contribute to a healthy gut microbiome in infants, and how this might protect babies from getting sick.

Key takeaways

  • The study explores how breast milk affects a baby's gut health.
  • It focuses on tiny messengers in breast milk called miRNAs.
  • Scientists are comparing breastfed and formula-fed babies.
  • Samples of breast milk and baby poo will be collected over the first year.
  • The goal is to understand how breast milk contributes to a healthy gut.
  • Participation involves providing samples and does not include extra medical visits.

Who may be eligible?

This study is looking for pregnant women in their last few months of pregnancy (the third trimester). To be considered, your pregnancy needs to be progressing normally, without complications like high blood pressure (pre-eclampsia) or diabetes that develops during pregnancy (gestational diabetes). You also shouldn't have had antibiotics or probiotics during your third trimester, and a specific test for 'Strep B' should have come back negative.

Once your baby is born, you'll need to decide if you'll be exclusively breastfeeding (or using a breast pump) or exclusively formula feeding. It's important that you don't choose a mix of both. You also need to be able to speak French, have a freezer at home to store samples, and be part of a social security scheme. You won't be able to join if you have a C-section, if your baby has certain health problems, or if you plan to stop breastfeeding before your baby is 60 days old.

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.

  1. Are you in your last three months of pregnancy, with a normal pregnancy?
  2. Have you not taken antibiotics or probiotics in your third trimester?
  3. Are you planning to exclusively breastfeed or exclusively formula-feed your baby?
  4. Do you have a freezer at home?
  5. Are you able to speak French?
  6. Are you part of a social security scheme?
Answer every question to see your result.

What does participation involve?

If you join this study, researchers will collect samples of your breast milk (if you're breastfeeding) and your baby's poo at different times over the baby's first year. These samples will be collected when your baby is around 10 days, 30 days, 60 days, 6 months, and 12 months old. You'll need a freezer at home to store some samples. The study will mainly involve providing these samples, and there are no extra doctor's visits mentioned beyond your usual check-ups. The total duration of your active participation, providing samples, would be for your baby's first 12 months.

Potential risks and benefits

Taking part in this study may not directly benefit you or your baby, but the information found could help other babies in the future by improving our understanding of infant health. There are very few risks involved, as it mainly requires collecting samples, which is not harmful. You are free to withdraw from the study at any time without giving a reason, and this will not affect your or your baby's medical care.

Locations (1)

  • Robert Debre Hospital Assistance Publique Hôpitaux de Paris
    Verified postcode
    Paris, France

Common questions

What are miRNAs?

miRNAs are tiny, natural particles found in breast milk that act like messengers, potentially influencing how a baby's body works and how gut bacteria grow.

Why is gut health important for babies?

A healthy gut with good bacteria is vital for preventing illnesses in babies and setting them up for good health later in life.

Do I have to breastfeed for this study?

The study needs both exclusively breastfed and exclusively formula-fed babies to compare, but you cannot do a mix of both.

What kind of samples will be collected?

Researchers will collect samples of your breast milk (if breastfeeding) and your baby's poo at several points during their first year.

How long does the study last for my baby?

Your baby will be part of the study for their first 12 months, providing samples at specific times during that period.

How to find out more

Alexis MOSCA, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of Breast Milk miRNAs on the Infant Gut Microbiota…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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