Recruiting

Bowel Preparation

Sponsor:

University of Manitoba

Code:

NCT06298461

Conditions

Crohn Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KleanLyte

Bi-PegLyte

Study Details

Brief summary:

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).

Conditions

Crohn Disease

Ulcerative Colitis

Study ID

NCT06298461

Start date

Jul 4, 2024

Status verified date

Jan, 2025

Completion date

May, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

418 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: OSS

active comparator: 2L PEG

Interventions

KleanLyte

Laxative for colonoscopy bowel preparation

Bi-PegLyte

Laxative for colonoscopy bowel preparation

Primary outcome measure

  • Quality of bowel cleanliness [ Time Frame: 1 year ]
  • Quality of bowel cleanliness [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, H2X 1R9

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Jan 8, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-01-08.