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

NCT06298461 | Recruiting Phase 4

• 1 other identifier: BowelPrep
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Volume of laxative intake

  1 year

• Endoscopic Outcomes

  1 year

• Endoscopic Outcomes

  1 year

• Endoscopic Outcomes

  1 year

• Endoscopic Outcomes

  1 year

Study Arms (2)

OSS

ACTIVE COMPARATOR

Drug: KleanLyte

2L PEG

ACTIVE COMPARATOR

Drug: Bi-PegLyte

Interventions

KleanLyte DRUG

Laxative for colonoscopy bowel preparation

OSS

Bi-PegLyte DRUG

Laxative for colonoscopy bowel preparation

2L PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnancy

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian IBD Research Consortium (CIRC): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, H2X 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Jane Castelli

CONTACT

289-880-3609; jcast@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 7, 2024
• Study Start: July 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)