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

University of Manitoba1 site in 1 country418 target enrollmentJuly 4, 2024

ConditionsCrohn Disease Ulcerative Colitis

InterventionsKleanLyte Bi-PegLyte

DrugsKleanLyte Bi-PegLyte

Overview

Phase: Phase 4
Intervention: KleanLyte
Conditions: Crohn Disease
Sponsor: University of Manitoba
Enrollment: 418
Locations: 1
Primary Endpoint: Quality of bowel cleanliness
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 4, 2024

End Date

May 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Manitoba

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Prior subtotal or total colorectal resection
•Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
•Colonoscopy being repeated because of poor preparation in the preceding six months.
•Allergies to the employed bowel preparations
•Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
•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.

Arms & Interventions

OSS

Intervention: KleanLyte

2L PEG

Intervention: Bi-PegLyte

Outcomes

Primary Outcomes

Quality of bowel cleanliness

Time Frame: 1 year

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.