RecruitingOBSERVATIONAL

Predicting IBD Treatment Outcomes With Gut Microbiome Analysis

This study aims to understand if the types of bacteria and fungi living in your gut (your microbiome) can help predict whether treatments for Crohn's disease will be effective. Researchers will collect samples like stool, fluid from your gut, and small tissue pieces during a routine colonoscopy. They will compare these samples from people with active Crohn's disease, those whose disease is quiet, and people without bowel disease. Over 12 months, they will see if certain gut bug patterns can tell us who will respond best to their Crohn's treatment. The goal is to find better ways to predict treatment success for Inflammatory Bowel Diseases (IBD).

At a glance

Status

Recruiting

Sponsor

University of British Columbia

Enrolment target

100

Start

01 Aug 2024

Estimated completion

01 Apr 2027

Inflammatory Bowel Diseases Crohn Disease

What is this study about?

Crohn's disease is a type of Inflammatory Bowel Disease (IBD) that causes long-term inflammation in your gut. It often comes and goes, meaning there are times when symptoms are bad (active disease) and times when they are quiet (quiescent). Finding the right treatment can sometimes take time, and doctors are always looking for better ways to predict how well a treatment will work for each person.

This study is trying to understand if the tiny living things in your gut – like bacteria and fungi, known as your 'microbiome' – can give us clues about how your Crohn's disease will respond to treatment. We know that these gut bugs play a big role in your health, and researchers believe that specific combinations or patterns of them might indicate if a treatment will be successful. By looking closely at these patterns, the study hopes to find 'signatures' that can help doctors choose the best treatment for you more quickly.

Researchers will collect different types of samples from people with Crohn's disease and healthy volunteers. They will then follow the participants for a year to see how their treatment for Crohn's disease progresses. The information gathered could lead to more personalised and effective care for people living with Crohn's disease in the future.

Key takeaways

Aims to link particular gut bugs to how well Crohn's disease treatments work.
Participation involves providing extra samples during a routine colonoscopy, stool samples, and blood samples.
Follow-up for 12 months to see how your treatment progresses.
No new treatments or procedures are involved.
Helps advance understanding of Crohn's disease for future patient care.

Who may be eligible?

This study is looking for adults aged 19 to 80 years old. If you have Crohn's disease that affects your lower small bowel or large bowel and can be seen during a colonoscopy, you might be able to join. You must be having a colonoscopy as part of your regular medical care, whether your disease is currently active or quiet.

They are also looking for healthy adults, aged 19 to 80, who are having a colonoscopy for bowel screening. However, if any inflammation is found during their colonoscopy, or if they have a close relative with IBD, they may not be able to join.

There are also some reasons why you might not be able to join, such as having active infection around the back passage (perianal Crohn's), having had recent bowel surgery, taking antibiotics in the last two months, or if you are pregnant or breastfeeding. The researchers want to make sure the study is safe and that results aren't affected by other factors.

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 19 and 80 years old?
Are you having a colonoscopy soon for routine care or screening?
Do you have Crohn's disease that can be seen during a colonoscopy, OR are you a healthy person having screening?
Have you avoided antibiotics in the last two months?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have samples collected during your routine colonoscopy. These samples include small tissue pieces from your bowel, as well as a special 'washing' of your bowel. You will also be asked to provide stool (poo) and blood samples. After your initial samples, you will be followed for a period of 12 months. During this time, the research team will monitor how your Crohn's disease responds to your treatment. This will involve checking your symptoms and any other tests your doctor normally requests for monitoring your condition. There are no additional visits or changes to your medication for this study; it simply involves collecting extra information during your existing care.

Potential risks and benefits

The potential benefits of taking part include helping researchers better understand Crohn's disease and potentially improving how treatments are chosen in the future. You will be helping to advance medical knowledge, which could lead to better outcomes for others living with IBD. The risks associated with this study are minimal, as the samples are collected during procedures you would have anyway, like a routine colonoscopy. There are no extra procedures or medications involved. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

GI Research Institute
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is the 'gut microbiome'?

It's the community of tiny living things, like bacteria and fungi, that live in your digestive system.

Will taking part change my Crohn's treatment?

No, this study will not change your current treatment for Crohn's disease. You will continue to receive care from your regular doctors.

What does 'quiescent disease' mean?

It means your Crohn's disease is currently quiet or inactive, with fewer symptoms.

Do I have to live in Canada to join?

Yes, this specific study is looking for adults living in British Columbia, Canada.

What happens to my samples after they are collected?

Your samples will be analysed by researchers to look for patterns in the gut microbes, helping them understand Crohn's disease better.

How to find out more

Fanny LeMarié, PhD

flemarie@ibdcentrebc.ca 6044414992 Official trial record

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