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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298461
• Other study ID #: BowelPrep
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 418
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian IBD Research Consortium (CIRC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Volume of laxative intake	Will compare completion of laxative intake.	1 year
Secondary	Endoscopic Outcomes	Will compare dysplasia detection rate.	1 year
Secondary	Endoscopic Outcomes	Will compare withdrawal time.	1 year
Secondary	Endoscopic Outcomes	Will compare total procedure time.	1 year
Secondary	Endoscopic Outcomes	Will compare cecal intubation rate	1 year
Secondary	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.	1 year
Secondary	Crohn's disease or ulcerative colitis flares after colonoscopy	A one month phone call to determine diagnosed flares within a month	One month
Secondary	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.	1 year