A Phase 4 interventional study of KleanLyte and Bi-PegLyte in Crohn Disease and Ulcerative Colitis, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University of Manitoba · Phase 4, Interventional, and Treatment
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).
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 418 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: KleanLyte
Drug: Bi-PegLyte
Laxative for colonoscopy bowel preparation
Laxative for colonoscopy bowel preparation
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.
Time frame: 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.
Time frame: 1 year
Volume of laxative intake
Will compare completion of laxative intake.
Time frame: 1 year
Endoscopic Outcomes
Will compare dysplasia detection rate.
Time frame: 1 year
Endoscopic Outcomes
Will compare withdrawal time.
Time frame: 1 year
Endoscopic Outcomes
Will compare total procedure time.
Time frame: 1 year
Endoscopic Outcomes
Will compare cecal intubation rate
Time frame: 1 year
Patient experience data
Will determine the proportion of patients in each group reporting: use of split dose and day before bowel preparation (even though they were prescribed split-dose) , incontinence episodes during bowel preparation and during travel to the colonoscopy appointment; total duration of sleep; number of nocturnal awakenings: patient willingness to repeat colonoscopy using the same preparation; pre-colonoscopy anxiety rating; difficulty with bowel preparation rating. The study specific patient questionnaire will be administered prior to the colonoscopy to avoid any contamination by the experience of the colonoscopy.
Time frame: 1 year
Crohn's disease or ulcerative colitis flares after colonoscopy
A one month phone call to determine diagnosed flares within a month
Time frame: One month
Endoscopic Outcomes
Will also compare the proportion of patients requiring repeat colonoscopy because of an inadequate bowel preparation. Will collect data on mucosal abnormality suspected by endoscopist to be due to bowel preparation.
Time frame: 1 year
Plan to share: No — No individual participant data will be shared.
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.
Of 51 non-industry phase 4 interventional studies under Crohn Disease, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 72. This study's planned 17 months is below that.
Counting every sponsor, half of 66 studies reached it within 56 months; a quarter within 35 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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