Crohn DiseasePhase 4NCT06298461
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
A Phase 4 study testing KleanLyte and Bi-PegLyte in people with Crohn Disease and Ulcerative Colitis, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- KleanLyte and Bi-PegLyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2024to May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
- Age > 18 years
- Out-patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, H2X 1R9
Banke Oketola, adebanke.oketola@umanitoba.ca
About this study
Official title: Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial
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).
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- KleanLyte, Bi-PegLyte
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KleanLyteDrug
Laxative for colonoscopy bowel preparation
Bi-PegLyteDrug
Laxative for colonoscopy bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| OSS | Active comparator | Not described Receives: Drug: KleanLyte |
| 2L PEG | Active comparator | Not described Receives: Drug: Bi-PegLyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
Volume of laxative intake
Will compare completion of laxative intake.
Measured: 1 year
Endoscopic Outcomes
Will compare dysplasia detection rate.
Measured: 1 year
Endoscopic Outcomes
Will compare withdrawal time.
Measured: 1 year
Endoscopic Outcomes
Will compare total procedure time.
Measured: 1 year
Endoscopic Outcomes
Will compare cecal intubation rate
Measured: 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.
Measured: 1 year
Crohn's disease or ulcerative colitis flares after colonoscopy
A one month phone call to determine diagnosed flares within a month
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start4 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian IBD Research Consortium (CIRC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298461
- Sponsor's protocol ID
- BowelPrep
- Status last verified
- Jan 2025
- First submitted
- 6 Feb 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06298461
- Acronym / sponsor ID
- BowelPrep
- Conditions
- Crohn Disease, Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian IBD Research Consortium (CIRC)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSS | Active comparator | Drug: KleanLyte |
| 2L PEG | Active comparator | Drug: Bi-PegLyte |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
- Age > 18 years
- Out-patients
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KleanLyteLaxative for colonoscopy bowel preparation | Drug | OSS |
| Bi-PegLyteLaxative for colonoscopy bowel preparation | Drug | 2L PEG |
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KleanLyte and Bi-PegLyte in people with Crohn Disease and Ulcerative Colitis, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Castelli (289-880-3609, jcast@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel cleanliness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.