Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Phase 4 · Testing KleanLyte and Bi-PegLyte · 1 site · University of Manitoba
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing KleanLyte (a drug) and Bi-PegLyte (a drug) as a possible treatment. Condition(s) listed: Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
- Age > 18 years
- Out-patients
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 418 participants are expected to take part.
- Start date: 2024-07-04.
- Main results expected around 2025-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Quality of bowel cleanliness (1 year)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease; Ulcerative Colitis |
| Lead sponsor | University of Manitoba |
| Collaborators | Canadian IBD Research Consortium (CIRC) |
| Enrollment | 418 (estimated) |
| Start date | 2024-07-04 |
| Primary completion (est.) | 2025-12 |
| First posted | 2024-03-07 |
| Last updated | 2025-01-08 |
| Official title | Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06298461 |
Interventions
- KleanLyte (Drug)
Laxative for colonoscopy bowel preparation - Bi-PegLyte (Drug)
Laxative for colonoscopy bowel preparation
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Manitoba | Winnipeg, Manitoba | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.