Active not recruitingNAINTERVENTIONAL

OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

The MEND study is looking into whether a specific type of plant-based fiber, called resistant starch, can help children and teenagers who have Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. The main goal is to see if this resistant starch can improve the natural balance of bacteria and other tiny living things in their gut, known as the 'gut microbiome'. Researchers believe that by making the gut microbiome healthier, they might be able to address the underlying causes of IBD. Participants will either receive the resistant starch or a placebo (a dummy treatment, which looks the same but has no active ingredient). This study is for young people aged 5 to 17 years old.

At a glance

Status

Active not recruiting

Phase

Sponsor

Children's Hospital of Eastern Ontario

Enrolment target

100

Start

03 Mar 2021

Estimated completion

31 Dec 2026

Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

What is this study about?

You might have heard of conditions like Crohn's disease or ulcerative colitis. These are types of Inflammatory Bowel Disease (IBD), where the gut becomes inflamed and causes symptoms like tummy pain, diarrhoea, and tiredness. Even when symptoms are under control, the underlying inflammation can still be present.

Our bodies are home to billions of tiny living things, especially in our gut. This collection is called the 'gut microbiome', and it plays a big role in our health. In people with IBD, this balance of gut bacteria might not be as healthy, which can contribute to their condition. This study, called MEND, wants to explore if a special type of fibre, called resistant starch, can help fix this imbalance.

Resistant starch is found naturally in certain plant foods. It's different from other types of starch because it isn't fully digested in your small intestine. Instead, it travels to your large intestine where it can feed the 'good' bacteria. Researchers hope that by giving individuals a carefully chosen resistant starch, it could make their gut microbiome healthier and help improve their IBD.

Key takeaways

The MEND study explores if a special plant-based fibre can help children and teens with IBD.
It aims to improve gut health and the balance of gut bacteria (microbiome).
Participants will receive either resistant starch or a placebo, and samples will be collected.
Suitable for ages 5-17 with IBD that's currently well-controlled or mild.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for young people aged between 5 and 17 years old who have already been diagnosed with Crohn's disease or ulcerative colitis. It's important that your IBD symptoms are currently well-controlled or only very mild. You also need to have been on a stable treatment plan for your IBD for at least a month, with no expected changes in the next month.

To join, you or your parent/guardian must be able to understand and agree to take part. You also need to be willing and able to follow the study's instructions, which include providing stool samples regularly. We're looking for individuals whose gut bacteria show a positive response to certain types of resistant starch when tested initially.

However, some things would mean you can't take part. This includes if you have an allergy to resistant starch, have diabetes, or are currently taking part in another medical study. You also can't join if you have other serious long-term health conditions that need regular medication, have recently had bowel surgery, or need antibiotics for more than two weeks. We also can't include anyone with drug or alcohol dependence that would make it hard to follow the study rules.

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 between 5 and 17 years old?
Do you have Crohn's disease or ulcerative colitis?
Are your IBD symptoms currently mild or well-controlled?
Have you been on the same IBD treatment for at least a month, with no changes expected soon?
Are you able and willing to provide stool samples?
Do you have any severe allergies (especially to resistant starch) or other major health conditions like diabetes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the MEND study, you'll be involved in a few steps. First, we'll collect an initial stool sample to check how your gut bacteria might respond to different types of resistant starch. If your gut bacteria are suitable, you’ll then be randomly assigned to either receive the resistant starch or a placebo (a dummy treatment that looks the same but has no active ingredients). This means neither you nor the study team will know which one you are receiving.

You will need to take the assigned treatment regularly. Throughout the study, you'll be asked to provide more stool samples at different times. We will also monitor your health and IBD symptoms. While the exact duration of your participation isn't specified in detail, studies like this often involve several visits or check-ins over a period of weeks or months. You will always be fully informed of the full schedule before you agree to take part.

Potential risks and benefits

Taking part in the MEND study could potentially offer a benefit by helping to improve your gut health and IBD symptoms, possibly even targeting the root cause of your condition. However, there's no guarantee that you will personally benefit, as you might receive the placebo or the resistant starch might not work for you. Potential risks are generally low with resistant starch, but some people might experience mild digestive upset like gas or bloating. All potential side effects will be fully explained to you. It's important to remember that joining a study is always voluntary, and you are free to withdraw at any time without giving a reason, and it won't affect your regular medical care.

Locations (1)

Children's Hospital of Eastern Ontario
Verified postcode
Ottawa, Canada

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a long-term condition where parts of your gut become inflamed, leading to symptoms like stomach pain and diarrhea. Crohn's disease and ulcerative colitis are the main types.

What is 'resistant starch'?

Resistant starch is a type of fibre found in plants. Your body doesn't fully digest it, so it travels to your large intestine where it can feed helpful gut bacteria.

What is a 'placebo'?

A placebo is a dummy treatment. It looks exactly like the real treatment but doesn't contain any active ingredients. This helps researchers see if the real treatment has an actual effect.

Will I know if I'm getting the resistant starch or the placebo?

No, in this study, neither you nor the study team will know who is getting the active treatment versus the placebo. This is called a 'blinded' study and helps make the results fair.

What is a 'gut microbiome'?

The gut microbiome is the collection of all the tiny living things, like bacteria, that live in your intestines. They play a big role in your health and digestion.