Not yet recruitingPHASE2INTERVENTIONAL

A Probiotic Based Intervention in Pregnancies Complicated by GDM

This research study is looking into whether a daily natural health supplement, containing a mix of 'good bacteria' (probiotics) and 'food' for these bacteria (prebiotics), can help pregnant people in the UK with gestational diabetes. Gestational diabetes can affect blood sugar levels during pregnancy. Scientists believe that having a healthy gut, especially the good bacteria living there, plays a big role in overall health, including how the body handles sugar. This study aims to see if taking this supplement can improve blood sugar control and balance the gut's healthy bacteria. Around 115 participants will be randomly chosen to either receive the supplement or a dummy pill (placebo) and will be followed until after their baby is born.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Queen's University

Enrolment target

173

Start

01 Oct 2025

Estimated completion

31 Dec 2029

Gestational Diabetes Mellitus (GDM)Microbiome, Human

What is this study about?

This study is exploring a new idea for pregnant people in the UK who have been diagnosed with gestational diabetes. Gestational diabetes means that your blood sugar levels are higher than normal during pregnancy. While it usually goes away after your baby is born, it's important to manage it to keep both you and your baby healthy.

Researchers are interested in how the 'good bacteria' living in our guts, called the microbiome, might affect our health. There's a growing belief that an imbalance in these gut bacteria could play a part in conditions like gestational diabetes and how our bodies handle sugar. This study will give some participants a special supplement that contains different types of beneficial bacteria (probiotics) and substances that help these bacteria grow (prebiotics), while others will receive a dummy pill.

The main goal of this study is to find out if this supplement can help improve blood sugar control in pregnant people with gestational diabetes. They also want to see if it changes the balance of gut bacteria. If successful, this could offer a natural and safe way to support mothers and babies during pregnancies affected by gestational diabetes.

Key takeaways

Exploring if probiotics/prebiotics can help manage gestational diabetes.
Participation involves taking a daily supplement until 6 weeks postpartum.
Study includes clinic visits, surveys, and samples.
A continuous glucose monitor will be worn for short periods.
Joining helps advance understanding and care for future mothers.
You can choose to leave the study at any time.

Who may be eligible?

This study is looking for pregnant individuals aged 16 or over who have been diagnosed with gestational diabetes. You'll need to be pregnant with one baby and have a documented live heartbeat. You should also be happy to provide certain samples, like stool samples, and agree to wear a continuous glucose monitor for certain periods.

For the study, you'll need to live in the study area and plan to give birth at Kingston Health Sciences Centre (KHSC). You also shouldn't have plans to use, or be currently using, certain substances like alcohol or recreational drugs after finding out you're pregnant.

There are also some health conditions that would prevent you from joining, such as severe high blood pressure in pregnancy, pre-eclampsia, or having taken certain antibiotics or anti-fungal medications recently. The study team will check all these details carefully to make sure the study is right for you.

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 16 years or older?
Do you have gestational diabetes?
Are you pregnant with one baby and have a documented live heartbeat?
Are you willing to provide stool samples?
Are you generally healthy, without certain serious pregnancy complications?
Are you able to attend appointments at Kingston Health Sciences Centre (KHSC)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a visit where the study will be fully explained, and you'll give your permission. You'll then be randomly chosen to receive either the active supplement or a dummy pill – you won't know which one you're getting. You'll start taking this daily supplement between 24 and 31 weeks of pregnancy.

Throughout the study, you'll have a total of three mandatory visits: one when you join, one at around 37 weeks of pregnancy, and one about six weeks after your baby is born. During these visits, the team will check your weight, height, blood pressure, and review your blood sugar control. You'll also be asked to complete some questionnaires about your diet and health, wear a device to monitor your blood sugar over a week, and provide some samples, including a rectal swab to check your gut bacteria. After your baby is born, you might also be asked to provide an infant stool sample.

You'll continue taking the supplement until six weeks after your baby is born. At this point, you'll find out whether you were on the active supplement or the dummy pill. You'll then have the option to join an extended part of the study where everyone receives the active supplement until your baby is six months old.

Potential risks and benefits

Taking part in a study like this could offer several potential benefits. While we can't guarantee personal advantages, you'll be actively monitoring your health, which might help manage your gestational diabetes. You'll also be contributing to important research that could help future pregnant people with gestational diabetes. There are no known serious risks associated with the probiotic and prebiotic supplement, as it's a natural health product, but there's always a small chance of mild side effects like an upset stomach, which you should report. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Queen's University & Kingston Health Sciences Centre
Verified postcode
Kingston, Canada

Common questions

What is a 'probiotic' and 'prebiotic' supplement?

A probiotic is a supplement containing 'good bacteria' thought to be helpful for our health. A prebiotic is like food that helps these good bacteria grow in your gut.

What is Gestational Diabetes Mellitus (GDM)?

GDM is a type of diabetes that develops during pregnancy. It means your blood sugar levels are higher than normal, which can affect both you and your baby.

Will I know if I'm taking the active supplement or a dummy pill?

During the main part of the study, neither you nor the study team will know. This is called a 'blinded' study. You'll find out at 6 weeks after your baby is born.

How many times will I need to visit the clinic?

You'll have three mandatory visits: one when you join, one around 37 weeks of pregnancy, and one approximately 6 weeks after your baby is born. There's an optional extra visit if you join the extension part of the study.

What happens after my baby is born?

You'll continue the study until 6 weeks after birth. At this point, you'll be told what group you were in, and you can choose whether or not to continue with an optional extension where everyone gets the active supplement until your baby is 6 months old.

How to find out more

Jessica Pudwell, MPH, MSc

jessica.pudwell@queensu.ca 613-549-6666 Official trial record

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