RecruitingOBSERVATIONAL

Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease

This study aims to understand how pregnant women's body microbes (like bacteria and fungi in the gut, vagina, and on skin), their diet, and breastmilk might affect inflammation in their baby's gut. They will measure a marker called fecal calprotectin (FCP) in babies, which shows gut inflammation. Researchers want to compare mothers with Inflammatory Bowel Disease (IBD) and those without, tracing how these factors change during pregnancy and for a year after birth. The goal is to identify patterns that lead to higher FCP in babies and find out if simple diet changes could help improve babies' long-term health, potentially reducing risks of conditions like asthma, eczema, and IBD later on.

At a glance

Status

Recruiting

Sponsor

University of British Columbia

Enrolment target

Start

20 Mar 2026

Estimated completion

01 Feb 2028

IBD (Inflammatory Bowel Disease)IBD IBD - Inflammatory Bowel Disease Pregnancy

What is this study about?

This study is designed to explore a really important question: how a mother's health, particularly her gut bacteria and what she eats during pregnancy, might influence her baby's gut health. We know that some babies, especially those born to mothers with Inflammatory Bowel Disease (IBD), tend to have higher levels of something called fecal calprotectin (FCP). FCP is like a warning sign for inflammation in the gut. When FCP levels are high in babies, it's been linked to a slightly higher chance of developing problems like asthma, eczema, or even IBD later in life.

The research wants to specifically look at the 'microbiome' – that's all the tiny bacteria, fungi, and other microbes living in and on our bodies, including in the gut, vagina, and even in breastmilk and on the skin. By checking the microbiome and dietary habits of pregnant women (both those with IBD and those without) and their babies, the scientists hope to find patterns. For example, they want to see if specific types of gut bacteria in the mother or certain foods she eats are connected to higher FCP levels in her baby. They'll also check the baby's own gut bacteria and diet to see what might be making their FCP levels rise.

Ultimately, the big picture goal is to use this information to help pregnant women and their babies. If we can understand these connections better, doctors might be able to suggest certain diets or lifestyle changes during pregnancy that could help reduce gut inflammation in babies, potentially protecting them from certain health issues as they grow up. It's about finding ways to give babies the best possible start.

Key takeaways

The study explores how a mother's gut health and diet might impact her baby's gut inflammation.
It involves pregnant women with and without Inflammatory Bowel Disease (IBD).
Researchers will collect samples like stool and record diet using a smartphone app.
The study lasts for one year after the baby is born.
Aims to find ways to improve babies' long-term health through dietary insights.
Participation will not directly change your medical care.

Who may be eligible?

To join this study, you need to be at least 19 years old and currently pregnant, specifically in your first, second, or early third trimester. You’ll also need to own or have regular access to a smartphone. This is because a special app will be used to record your diet.

If you have Inflammatory Bowel Disease (IBD), you can join if you have a confirmed diagnosis, whether your IBD is currently active or not. If you don't have IBD, you can also join as a 'control' participant.

There are some reasons why you might not be able to join. These include if you can't give your consent, have had certain serious illnesses like bowel cancer or kidney disease, or have conditions like HIV/AIDS. If your baby has known chromosomal or structural problems, or if you have other immune system diseases like rheumatoid arthritis, you wouldn't be able to participate. Also, if you've taken certain supplements (prebiotics, probiotics, postbiotics) or had a tummy bug recently, or travelled outside Canada/US in the last month, you might be excluded. For those with IBD, if you have active IBD around your bottom area or outside your gut, you wouldn't be able to join.

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 19 years old or older and pregnant?
Do you have a smartphone you can use regularly?
If you have IBD, has it been diagnosed by a doctor?
Have you *not* had serious gut surgery or other severe health conditions?
Have you *not* taken probiotic/prebiotic supplements in the last month?
Have you *not* had a tummy bug in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved both during your pregnancy and for a year after your baby is born. The study involves collecting several types of samples and information at specific times.

During your pregnancy (around 34-35 weeks), you'll provide a stool sample (for gut bacteria and FCP levels) and a vaginal swab. You'll also use a smartphone app for three days to record everything you eat and drink. Two weeks, three months, and one year after your baby is born, you and your baby will both provide stool samples. At these times, you'll also record your diet for three days using the app. You can also choose to provide breastmilk and breast skin swab samples if you are breastfeeding. Throughout this year, the researchers will also keep track of health information about you and your baby. There are no specific medications given as part of this study.

Potential risks and benefits

Taking part in this study won't directly improve your or your baby's health at this moment. However, the information gathered could help us understand how to improve the health of many babies in the future by helping researchers develop better advice for pregnant women. The main risks are minor discomfort from collecting samples like stool or swabs, and the time commitment involved. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

BC Children's Hospital Research Institute
Verified postcode
Vancouver, Canada· Not yet recruiting
BC Children's Hospital Research Institute
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is fecal calprotectin (FCP)?

FCP is a protein found in your poo. Higher levels can be a sign of inflammation (irritation) in the gut.

What is the 'microbiome'?

The microbiome is made up of all the tiny living things, like bacteria and fungi, that live inside and on our bodies, especially in our gut.

Will taking part affect my medical care?

No, joining or leaving the study will not affect the medical care you or your baby receive from your doctors.

Do I need to change my diet?

No, you don't need to change your diet for the study. You'll just be asked to record what you normally eat.

How long will I be involved in the study?

You'll be involved during your pregnancy and then for about one year after your baby is born.

How to find out more

Genelle Lunken, PhD, RD

genelle.lunken@bcchr.ca 7782327016 Official trial record

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