Actively Recruiting
Bowel Preparation for Colonoscopy Among Individuals With Crohn's Disease and Ulcerative Colitis A Randomized Trial Comparing Oral Sulfate Solution and 2L Polyethylene Glycol
Led by University of Manitoba · Updated on 2025-01-08
418
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
C
Canadian IBD Research Consortium (CIRC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and tolerability of two different laxatives used for bowel preparation before a colonoscopy in adults with inflammatory bowel disease (IBD), specifically Crohn's disease or ulcerative colitis. The study focuses on evaluating oral sulfate solution (OSS) against a 2-liter polyethylene glycol (PEG) solution to determine which laxative better prepares the bowel for colonoscopy and is easier for patients to tolerate. This is a phase 4 randomized controlled trial involving individuals with these IBD conditions. Participants will receive one of two bowel preparation treatments: KleanLyte, an oral sulfate solution laxative, or Bi-PegLyte, a polyethylene glycol-based laxative. Both are taken before colonoscopy to clean the bowel. The study compares these two treatments to assess their quality in bowel cleansing and how well patients tolerate them. The treatments are administered according to standard colonoscopy preparation protocols. During the study, participants will undergo assessments to measure the quality of bowel cleanliness one year after treatment. Researchers will monitor how effectively each laxative cleans the bowel and track any tolerability issues reported by participants. The study includes adults over 18 years old who are outpatients scheduled for colonoscopy. Safety monitoring includes evaluating any adverse health conditions or complications related to the bowel preparation methods throughout the trial.
CONDITIONS
Official Title
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Crohn's disease or ulcerative colitis and scheduled or about to be scheduled for colonoscopy
- Age over 18 years
- Outpatient status
You will not qualify if you...
- Prior subtotal or total colorectal resection
- Known kidney problems, congestive heart failure, liver cirrhosis, or severe electrolyte imbalance
- Repeat colonoscopy due to poor preparation in the last six months
- Allergies to the bowel preparation solutions used
- Presence of toxic megacolon, ileus, or suspected/diagnosed bowel obstruction
- Being too ill to undergo full colonoscopy preparation as judged by physician
- Hospitalized Crohn's or ulcerative colitis patients
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Manitoba
Winnipeg, Manitoba, Canada, H2X 1R9
Actively Recruiting
Research Team
J
Jane Castelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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