Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults

NCT07127237 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HospitalCDMQ
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Boston scale

  Scale used to evaluate the quality of bowel preparation during video colonoscopy. Score 0-9; adequate preparation (Boston ≥ 2 points in each colonic segment), inadequate preparation (Boston \< 2 points in any of the segments).

  Periprocedural

Secondary Outcomes (3)

• Tolerability of bowel preparation. Presence or absence of the following symptoms during bowel preparation: nausea, vomiting, abdominal pain or distension, headache, dizziness, fatigue, palpitations, and rectal bleeding.

  Periprocedural

• Overall adenoma detection rate

  Until the completion of the studies. Average 1 year

• Overall cecal intubation rate

  Until the completion of the studies. Average 1 year.

Study Arms (2)

Bisacodyl

EXPERIMENTAL

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: Bisacodyl 5 MG

Prucaloprida

EXPERIMENTAL

On the day prior to the procedure, the group receiving prucalopride will take one 2 mg tablet 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

Interventions

Bisacodyl 5 MG DRUG

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.

Bisacodyl

Prucalopride 2mg DRUG

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.

Prucaloprida

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over 18 years of age.
• Without prior colonic surgical interventions.
• Who attend the Digestive Endoscopy service to undergo a colonoscopy.

You may not qualify if:

• Patients who voluntarily choose not to participate in the study.
• Pregnant women.
• Patients with rectocolonic resections and/or ileostomies.
• Inflammatory bowel disease.
• Inadequate bowel preparation in a previous colonoscopy.
• Suspected intestinal obstruction or perforation.
• Intestinal intussusception.
• Melena.
• Oral iron intake within the last 10 days.
• Emergency colonoscopies.
• Hypersensitivity to any component of the bowel preparation solutions.
• Chronic kidney disease on dialysis.
• Uncorrected severe electrolyte imbalances.
• Major psychiatric disorders.
• Low intellectual quotient.

Sponsors & Collaborators

• Hospital de Clínicas Dr. Manuel Quintela: lead

MeSH Terms

Interventions

Bisacodyl; prucalopride

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ignacio Moratorio

CONTACT

+59824871515; ignacio.moratorio@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share