Comparing bowel preparation methods for colonoscopy in patients with Crohn's and Ulcerative Colitis

Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial

This study is testing which bowel prep method, oral sulfate solution or polyethylene glycol, works better and is easier for adults with Crohn's disease or ulcerative colitis who need a colonoscopy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 418 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Manitoba (other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT06298461 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and tolerability of two bowel preparation laxatives, oral sulfate solution (OSS) and 2L polyethylene glycol (PEG) solution, in individuals with inflammatory bowel disease (IBD) who are scheduled for colonoscopy. By comparing these two preparations, the study seeks to determine which option provides better outcomes for patients undergoing this procedure. Participants will be outpatients aged over 18 with Crohn's disease or ulcerative colitis. The study is designed to enhance the colonoscopy experience for these patients by identifying the more effective and tolerable preparation method.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with Crohn's disease or ulcerative colitis who are scheduled for a colonoscopy.

Not a fit: Patients who have had prior colorectal surgery, severe comorbidities, or are currently hospitalized may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved bowel preparation methods for patients with Crohn's and Ulcerative Colitis, enhancing their comfort and the effectiveness of colonoscopy.

How similar studies have performed: Other studies have explored bowel preparation methods in IBD patients, but this specific comparison of OSS and 2L PEG is novel.

Eligibility criteria

Inclusion Criteria:

1. Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
2. Age \> 18 years
3. Out-patients

Exclusion Criteria:

1. Prior subtotal or total colorectal resection
2. Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
3. Colonoscopy being repeated because of poor preparation in the preceding six months.
4. Allergies to the employed bowel preparations
5. Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
6. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients.
7. Pregnancy

Where this trial is running

Winnipeg, Manitoba

• University of Manitoba — Winnipeg, Manitoba, Canada (RECRUITING)

Study contacts

• Study coordinator: Jane Castelli

Conditions: Crohn Disease, Ulcerative Colitis