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

University of Manitoba

Status and phase: Enrolling; Phase 4

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Drug: KleanLyte; Drug: Bi-PegLyte

Study type: Interventional

Funder types: Other

Identifiers

NCT06298461

BowelPrep

Details and patient eligibility

About

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).

Enrollment: 418 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

418 participants in 2 patient groups

OSS

Active Comparator group

Treatment:

Drug: KleanLyte

2L PEG

Active Comparator group

Treatment:

Drug: Bi-PegLyte