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Recruiting NCT06298461

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

Phase IV Interventional Crohn Disease Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KleanLyte, Bi-PegLyte.
Who it may be relevant to
Registry conditions: Crohn Disease, Ulcerative Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug KleanLyte
    Laxative for colonoscopy bowel preparation
  • Drug Bi-PegLyte
    Laxative for colonoscopy bowel preparation

Primary outcome measures

  • Quality of bowel cleanliness [Time frame: 1 year]
  • Quality of bowel cleanliness [Time frame: 1 year]
Secondary outcome measures (8)
  • Volume of laxative intake [Time frame: 1 year]
  • Endoscopic Outcomes [Time frame: 1 year]
  • Endoscopic Outcomes [Time frame: 1 year]
  • Endoscopic Outcomes [Time frame: 1 year]
  • Endoscopic Outcomes [Time frame: 1 year]
  • Patient experience data [Time frame: 1 year]
  • Crohn's disease or ulcerative colitis flares after colonoscopy [Time frame: One month]
  • Endoscopic Outcomes [Time frame: 1 year]

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.
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Manitoba — Winnipeg

Identifiers

NCT: NCT06298461 · BowelPrep

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗