Improving Bowel Preparation for the Colon Capsule

Queen's University

Status and phase: Completed; Phase 3

Conditions: Quality of Bowel Preparation for the Colon Capsule; Colon Capsule Polyp Detection; Colon Capsule Completion Rates

Treatments: Drug: Prucalopride; Drug: Bisacodyl; Drug: PEG; Drug: Picosalax; Procedure: Colonoscopy; Procedure: Colon capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01655095

DMED-1478-12

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female patients between the ages of 18 and 75
• Patients being referred for colonoscopy

Exclusion criteria

• Symptoms of dysphagia
• Bowel obstruction or ileus
• Known stricture or fistula
• Inflammatory bowel disease
• Previous small or large bowel surgery
• Severe gastroparesis or motility disorder
• Renal impairment (GFR<55 within 3 months of study)
• Congestive heart failure (NYHA III or IV)
• Ischemic heart disease
• Cirrhosis or severe hepatic dysfunction (ascites or lab result INR>2)
• History of serious arrhythmia
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

PEG and Prucalopride

Experimental group

Treatment:

Drug: Prucalopride

Drug: PEG

Procedure: Colon capsule

Procedure: Colonoscopy

Picosalax and Prucalopride

Experimental group

Treatment:

Drug: Prucalopride

Drug: Bisacodyl

Procedure: Colon capsule

Drug: Picosalax

Procedure: Colonoscopy