Active not recruitingOBSERVATIONAL

The Pregnancy & Early Life Study

The Pregnancy & Early Life Study wants to understand how the tiny living germs (microbes) in a mum's and baby's gut affect health. These microbes are super important for things like digestion, a strong immune system, and fighting off infections. We know that things like antibiotics or how a baby is born can change these microbes, potentially raising the risk of allergies or gut problems later on. This study will follow pregnant women and their babies to see how these microbes develop and what factors keep them healthy. By learning more, we hope to better understand how to support babies' health from the very beginning.

At a glance

Status

Active not recruiting

Sponsor

Quadram Institute Bioscience

Enrolment target

261

Start

01 May 2019

Estimated completion

01 Dec 2025

Pregnancy

What is this study about?

When we talk about the 'gut', we mean your tummy and intestines. This area is home to a huge community of tiny living organisms, called microbes. They're so small you can't see them without a microscope, but they play a massive role in keeping us healthy. They help us get nutrients from food, train our immune system (which protects us from illness), and even fight off bad germs.

For new mums and their babies, these microbes are especially important. During pregnancy and early life, a baby's gut starts to fill with these helpful microbes. Things like antibiotics, the way a baby is delivered (vaginal birth or C-section), or what a mum eats can all change this community of microbes. Sometimes these changes might mean a baby is more likely to develop problems like allergies, infections, or tummy issues later on.

This study aims to discover how a mother's microbes pass to her baby and how a healthy mix of microbes develops in the baby's gut. We'll be looking at what influences this process — like diet, or if antibiotics are used. By tracking these changes over a long period, we hope to get a much clearer picture of what a healthy start truly means for a baby's developing gut and overall health.

Key takeaways

We're studying how tiny gut germs in mums and babies affect health.
Understanding these germs could help prevent allergies and gut problems in babies.
Participation involves collecting samples (urine, stool, swabs) and filling out questionnaires.
The study lasts for about 31 months.
You can choose not to provide blood or breast milk samples.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be pregnant and no more than 22 weeks along when you agree to participate. You should be planning to have your baby at the Norfolk & Norwich University Hospital (NNUH) or at home in that area. Your Body Mass Index (BMI) should be between 18 and 35.

There are also some things that would mean you couldn't take part. For example, if you've recently taken antibiotics, antifungals, or antivirals (in the last 3 months), or steroids (in the last 6 months). Also, if you're a smoker, if you have certain long-term gut or liver problems, or if you're already taking part in another medical study, you wouldn't be able to join.

We're also looking for mums who will be raising their own babies, so if you're carrying a baby for someone else (surrogacy) or planning to place your baby for adoption, this study wouldn't be suitable.

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 22 weeks pregnant or less?
Do you plan to give birth at NNUH or at home in the area?
Are you between 18 and 35 BMI?
Have you avoided antibiotics, antifungals, or antivirals in the last 3 months, and steroids in the last 6 months?
Are you a non-smoker?
Are you raising your own baby?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for about 31 months, which is just over two and a half years. During this time, you'll be asked to provide some samples. These include urine and stool (poo) samples, along with swabs from your lower vagina and skin. If you choose to breastfeed, we might also ask for a breast milk sample, and blood samples are also an optional part of the study.

Once your baby is born, we'll ask you to collect their first poo sample (meconium), regular poo samples, and skin swabs. You'll also be asked to fill out three different types of questionnaires about yourself and your baby throughout the 31 months. We'll also ask you to make space for a small freezer in your home to store some of these samples.

Potential risks and benefits

Taking part in research studies doesn't usually offer direct personal benefits, but the information we gather could help many other mums and babies in the future by improving our understanding of early health. The main risks involve the time and effort needed to collect samples and fill out questionnaires. Taking samples such as urine or stool is generally very safe, and blood samples (if you choose to give them) carry only a small risk of bruising or discomfort. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your care or relationship with your medical team.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quadram Institute Bioscience
Verified postcode
Norwich, United Kingdom

Common questions

What is the main goal of this study?

We want to understand how a mother's tiny germs (microbes) influence her baby's gut health and development, potentially reducing the risk of allergies and other conditions later on.

How long will I be involved if I join?

Your involvement in the study will be for approximately 31 months, which is about two and a half years.

Do I have to give blood samples?

No, giving blood samples is completely optional. You can still participate in the study even if you prefer not to give blood.

What kind of samples will I need to collect?

You'll be asked to collect urine, stool (poo), and skin/vaginal swabs. After your baby is born, we'll also ask for their first poo (meconium), regular poo, and skin swabs.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.