RecruitingPHASE4INTERVENTIONAL

Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.

This research study is looking into two different types of laxatives, KleanLyte and Bi-PegLyte, which are used to prepare your bowels before a colonoscopy. If you have Crohn's disease or ulcerative colitis and are scheduled for a colonoscopy, this study wants to find out which of these two preparations is better. Researchers will compare how well each laxative cleans the bowel and also how easy it is for people to take and tolerate. The goal is to find the most effective and tolerable option for individuals with inflammatory bowel disease (IBD) like Crohn's or ulcerative colitis when they need a colonoscopy.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Manitoba

Enrolment target

418

Start

04 Jul 2024

Estimated completion

01 May 2026

Crohn Disease Ulcerative Colitis

What is this study about?

When you need a colonoscopy, it's really important that your bowel is properly cleaned out beforehand. This allows the doctor to get a clear view of your bowel lining and spot any problems. For people with conditions like Crohn's disease or ulcerative colitis, finding a bowel preparation that works well and isn't too difficult to take can be especially important.

This study specifically looks at two commonly used bowel preparations: KleanLyte and Bi-PegLyte. Doctors want to understand which of these two options is more effective at making sure the bowel is ready for a colonoscopy. They also want to know which one people find easier to drink and tolerate, as bowel preparations can sometimes be unpleasant.

The findings from this study could help doctors decide the best way to prepare patients with Crohn's or ulcerative colitis for a colonoscopy in the future. This could lead to better experiences for patients and clearer results from their colonoscopies.

Key takeaways

Compares two bowel preparations for colonoscopy.
For adults with Crohn's disease or ulcerative colitis.
Aims to find which is more effective and easier to use.
Could improve future colonoscopy preparations for IBD patients.
Participation involves taking one of the study laxatives before your scheduled colonoscopy.

Who may be eligible?

You might be able to take part in this study if you are an adult (over 18 years old) who has Crohn's disease or ulcerative colitis and are planning to have a colonoscopy soon. You would need to be attending as an outpatient, meaning you're not currently staying in hospital.

However, there are some reasons why you wouldn't be able to join. For example, if you've already had surgery that removed part or all of your large bowel, or if you have certain health problems like serious kidney or heart issues. You also can't join if taking either of the study laxatives would be dangerous for you, or if you've had a colonoscopy that failed because of poor preparation in the last six months.

Other reasons not to participate include having severe health problems like a bowel blockage, or if your doctor thinks you are too unwell to go through the bowel preparation process. Being pregnant would also prevent you from joining the study.

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 over 18 years old?
Do you have Crohn's disease or ulcerative colitis?
Are you scheduled for a colonoscopy?
Are you generally well enough to prepare for a colonoscopy (as judged by your doctor)?
Have you *not* had major bowel surgery (like removal of most/all of your large bowel)?
Are you *not* pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given one of the two bowel preparation laxatives (KleanLyte or Bi-PegLyte) to use before your colonoscopy. The study specifically focuses on comparing these two preparations, so your main involvement will be taking the preparation as instructed and then having your colonoscopy as planned. There aren't extra visits beyond your scheduled clinic appointments and colonoscopy. You'll complete your bowel preparation at home, and doctors will assess how well it worked during your colonoscopy. The total duration of your participation would mainly cover the time leading up to and including your colonoscopy.

Potential risks and benefits

Taking part in this study could help us learn which bowel preparation is best for people with Crohn's or ulcerative colitis undergoing a colonoscopy. This might lead to improved preparation methods in the future. As with any medication, there's always a small chance of side effects from the laxatives, which your doctor will discuss with you. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Manitoba
Verified postcode
Winnipeg, Canada· Recruiting

Common questions

What is a colonoscopy?

A colonoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your large bowel (colon) and rectum.

Why do I need bowel preparation?

Bowel preparation is medicine you take to clean out your bowel before a colonoscopy. This is essential so the doctor can see your bowel lining clearly and find any polyps or other problems.

What are Crohn's disease and ulcerative colitis?

These are long-term conditions that cause inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness.

Will I know which laxative I'm taking?

The study aims to compare the two laxatives fairly. Your study doctor will explain how it works when you discuss joining.

What happens if I don't want to join the study?

That's absolutely fine. Your medical care will not be affected in any way if you decide not to take part in the study.

How to find out more

Jane Castelli

jcast@mcmaster.ca 289-880-3609 Official trial record

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