RecruitingNAINTERVENTIONAL

Personalized Anti-Inflammatory Fibres in Ulcerative Colitis

This study is investigating if two types of dietary fibre, called acacia gum and microcrystalline cellulose, can help reduce inflammation in the gut for people living with ulcerative colitis. Ulcerative colitis is a long-term condition causing inflammation in the large bowel. The researchers will compare these fibre supplements to a 'placebo' – a substance that looks the same but contains no fibre – to see if they can lower a key marker of inflammation found in stool samples. Participants will add their assigned fibre or placebo to their daily diet for six weeks. They will have check-ups at the clinic at the beginning, middle, and end of this period, where they'll provide stool and blood samples and fill out questionnaires. This research aims to find new, gentle ways to manage ulcerative colitis alongside existing treatments.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

03 Jun 2025

Estimated completion

01 Dec 2027

Ulcerative Colitis

What is this study about?

Ulcerative colitis is a condition that causes inflammation in the large bowel, and it's becoming more common. While there are treatments available, they sometimes come with side effects. This means doctors and researchers are always looking for new and gentler ways to help manage the condition and improve people's lives.

One promising area is exploring the role of gut bacteria, also known as the gut microbiome. We know that the types of bacteria in our gut can affect inflammation. Dietary fibre can change the gut bacteria and encourage them to produce helpful substances that might reduce inflammation. This study wants to see if specific types of fibre, acacia gum and microcrystalline cellulose, can make a positive difference for people with ulcerative colitis by reducing gut inflammation.

Participants in this study will add a fibre supplement – either acacia gum, microcrystalline cellulose, or a placebo (a harmless, non-fibre substance that looks the same) – to their daily diet for six weeks. Researchers will then check if these fibres help to reduce inflammation compared to the placebo, using samples collected during clinic visits. The aim is to find effective, complementary ways to support people with ulcerative colitis.

Key takeaways

This study explores if fibre supplements can reduce gut inflammation in ulcerative colitis.
It compares two fibres (acacia gum, microcrystalline cellulose) to a dummy treatment (placebo).
Participation involves taking a supplement daily for six weeks and three clinic visits.
Researchers will check inflammation and gather health information.
The goal is to find gentle, complementary ways to manage ulcerative colitis.
You won't know if you're taking a fibre or the placebo.

Who may be eligible?

This study is looking for people who have been diagnosed with ulcerative colitis and currently have some active inflammation, even if they aren't experiencing many symptoms. You might be eligible if a specific test for inflammation in your stool shows active disease, or if your doctor has assessed your symptoms as active.

To join, you need to be at least 14 years old and weigh more than 40kg. It's important that your ulcerative colitis medication has been stable for at least three months before the study starts. This means no big changes to your treatment plan, although minor adjustments (like for weight changes) are usually fine.

However, you wouldn't be able to join if you have other bowel conditions like Crohn's disease, or if you have any blockages or serious problems with your digestive system. People with other significant health issues, such as severe heart, kidney, or lung disease, uncontrolled diabetes, or a severe ongoing infection, would also not be eligible.

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.

Do you have a confirmed diagnosis of ulcerative colitis?
Is your ulcerative colitis currently active (even if symptoms are mild)?
Are you at least 14 years old and weigh over 40kg?
Have your ulcerative colitis medications been stable for the last three months?
Do you have any other serious health conditions or digestive problems?
Can you commit to daily supplement use and three clinic visits over six weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to add a specific fibre supplement (either acacia gum, microcrystalline cellulose, or a placebo) to your daily diet for six weeks. This will be alongside your usual diet and medications. You'll need to visit the clinic three times in total: once at the beginning of the study, another visit after three weeks, and a final visit at the end of the six weeks.

During these clinic visits, you'll provide small samples of your stool and blood. You'll also be asked to complete some questionnaires about your health and how you're feeling. The total duration of your active participation in the study will be six weeks.

Potential risks and benefits

The potential benefits of taking part could include providing valuable information that helps improve care for people with ulcerative colitis and potentially finding a new, gentle way to manage your own inflammation. However, there's no guarantee that you will personally benefit from the fibre supplements. Possible risks might include mild digestive upsets like bloating or changes in bowel habits, which are common with dietary changes. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny open sores, called ulcers.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real fibre supplement but doesn't contain any active ingredients. It helps researchers fairly compare results.

Will I know which fibre supplement I'm getting?

No, this is a 'blinded' study, meaning neither you nor the researchers will know whether you are receiving acacia gum, microcrystalline cellulose, or the placebo. This helps ensure fair and unbiased results.

How long will I need to be in the study?

Your active involvement in the study, including taking the supplement and attending clinic visits, will last for six weeks.

Do I need to change my current medications for ulcerative colitis?

No, it's important that your current ulcerative colitis medications have been stable for at least three months before starting the study, and you will continue to take them as usual during the study.

How to find out more

Eytan Wine, MD, PhD

wine@ualberta.ca (780) 248-5494 Official trial record

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