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Recruiting

NCT Number: NCT06298461

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Manitoba

Winnipeg, Manitoba, H2X 1R9, Canada

Location status: Recruiting

Location contact

Banke Oketola

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KleanLyte

Drug

Laxative for colonoscopy bowel preparation

Bi-PegLyte

Drug

Laxative for colonoscopy bowel preparation

Primary outcomes

  1. Quality of bowel cleanliness

    Time frame: 1 year

    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.

  2. Quality of bowel cleanliness

    Time frame: 1 year

    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.

Secondary outcomes

  1. Volume of laxative intake

    Time frame: 1 year

    Will compare completion of laxative intake.

  2. Endoscopic Outcomes

    Time frame: 1 year

    Will compare dysplasia detection rate.

  3. Endoscopic Outcomes

    Time frame: 1 year

    Will compare withdrawal time.

  4. Endoscopic Outcomes

    Time frame: 1 year

    Will compare total procedure time.

  5. Endoscopic Outcomes

    Time frame: 1 year

    Will compare cecal intubation rate

  6. Patient experience data

    Time frame: 1 year

    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.

  7. Crohn's disease or ulcerative colitis flares after colonoscopy

    Time frame: One month

    A one month phone call to determine diagnosed flares within a month

  8. Endoscopic Outcomes

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Castelli

CONTACT

[email protected]

289-880-3609

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian IBD Research Consortium (CIRC)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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