NCT01655095

Improving Bowel Preparation for the Colon Capsule

Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America. The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit. Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon. The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.

Conditions

• Quality of Bowel Preparation for the Colon Capsule
• Colon Capsule Completion Rates
• Colon Capsule Polyp Detection

Interventions

Type	Name	Description
DRUG	PEG	PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
DRUG	Prucalopride	Prucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time.
DRUG	Picosalax	One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
DRUG	Bisacodyl	Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
PROCEDURE	Colon capsule	The colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy.
PROCEDURE	Colonoscopy	At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-08-01
• Last updated: 2015-12-03

Locations

1 site across 1 country: Canada