Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults
NCT07127237 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2025-08-17
Summary
The objective of this randomized clinical trial is to compare prucalopride versus bisacodyl as a stimulant agent for bowel cleansing preparation prior to colonoscopy in patients undergoing the procedure at the Endoscopy Unit of the Hospital de Clínicas. The main research questions this study aims to answer are:
Is prucalopride superior or equivalent to bisacodyl as a stimulant agent for bowel cleansing preparation before colonoscopy? Is the tolerability of prucalopride better, equivalent, or worse compared to bisacodyl? The investigators will compare the standard bowel cleansing preparation using polyethylene glycol (PEG) in combination with either bisacodyl or prucalopride as the stimulant agent.
Participants will be randomized into two groups, both receiving the same base preparation with different stimulant agents.
Conditions
- Bowel Preparation
Interventions
- DRUG
-
Bisacodyl 5 MG
On the day prior to the procedure, the group receiving bisacodyl will take 4 tablets (5 mg each) at 4:00 PM. Subsequently, at 6:00 PM, they will dissolve 3 sachets of PEG in 3 liters of water (1 sachet per liter) and ingest half of the preparation, that is, 1.5 liters over a period of 2 hours. At 10:00 PM, they will ingest the remaining 1.5 liters over another 2-hour period.
- DRUG
-
Prucalopride 2mg
On the day prior to the procedure, the group receiving prucaloprida will take 1 tablet (2 mg) at 4:00 PM. Subsequently, at 6:00 PM, they will dissolve 3 sachets of PEG in 3 liters of water (1 sachet per liter) and ingest half of the preparation, that is, 1.5 liters over a period of 2 hours. At 10:00 PM, they will ingest the remaining 1.5 liters over another 2-hour period.
Sponsors & Collaborators
-
Hospital de Clínicas Dr. Manuel Quintela
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
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