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

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

The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: KleanLyte; Drug: Bi-PegLyte

• Study Type: Interventional
• Enrollment (Estimated): 418
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jane Castelli; Phone Number: 289-880-3609; Email: jcast@mcmaster.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, H2X 1R9
      • Recruiting
      • University of Manitoba
      • Contact: Banke Oketola; Email: adebanke.oketola@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2L PEG	Drug: Bi-PegLyte; Laxative for colonoscopy bowel preparation
Active Comparator: OSS	Drug: KleanLyte; Laxative for colonoscopy bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of bowel cleanliness	The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by Boston Bowel Preparation Scale Score ≥2 in all segments.	1 year
Quality of bowel cleanliness	The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by the Ottawa scale score as a binary adequate/inadequate score (≤7) will be recorded.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of laxative intake	Will compare completion of laxative intake.	1 year
Endoscopic Outcomes	Will compare dysplasia detection rate.	1 year
Endoscopic Outcomes	Will compare withdrawal time.	1 year
Endoscopic Outcomes	Will compare total procedure time.	1 year
Endoscopic Outcomes	Will compare cecal intubation rate	1 year
Patient experience data	Will determine the proportion of patients in each group reporting: use of split dose and day before bowel preparation (even though they were prescribed split-dose) , incontinence episodes during bowel preparation and during travel to the colonoscopy appointment; total duration of sleep; number of nocturnal awakenings: patient willingness to repeat colonoscopy using the same preparation; pre-colonoscopy anxiety rating; difficulty with bowel preparation rating. The study specific patient questionnaire will be administered prior to the colonoscopy to avoid any contamination by the experience of the colonoscopy.	1 year
Crohn's disease or ulcerative colitis flares after colonoscopy	A one month phone call to determine diagnosed flares within a month	One month
Endoscopic Outcomes	Will also compare the proportion of patients requiring repeat colonoscopy because of an inadequate bowel preparation. Will collect data on mucosal abnormality suspected by endoscopist to be due to bowel preparation.	1 year

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian IBD Research Consortium (CIRC)

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Crohn Disease
• Other Study ID Numbers: BowelPrep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No