NCT06298461 Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
| NCT ID | NCT06298461 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Manitoba |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 418 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 418 participants in total. It began in 2024-07-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06298461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06298461 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06298461 currently recruiting?
Yes, NCT06298461 is actively recruiting participants. Contact the research team at jcast@mcmaster.ca for enrollment information.
Where is the NCT06298461 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT06298461 clinical trial?
NCT06298461 is sponsored by University of Manitoba. The trial plans to enroll 418 participants.