NCT02353208

The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy

The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: a Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited by the battery life. In 20% of cases, the recording stops before the entire length of small bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the brain sends signal to the bowel to speed up motility. In this study the investigators wish to determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility and improve the rate of complete small bowel examination.

Detailed description

This is a prospective, randomized, single-blinded controlled trial. Subjects ages 19 years and older referred for capsule endoscopy (CE) at the GI Clinic, St. Paul's Hospital will be invited to participate in the study. We will be recruiting 122 subjects and will randomize them into 2 groups: control group and treatment group. Control subjects will undergo the standard capsule endoscopy procedure. Subjects in Treatment group will undergo sham feeding in addition to the standard capsule endoscopy procedure. Both control and treatment subjects in this study will be required to swallow a capsule (the size of a large pill) named Given Imaging SB3® Capsule. The investigator and the video reader will be blinded (single-blinded study). Times will be recorded at: first gastric image, first duodenal image and first cecal image. The diagnostic yield for controls and subjects will be calculated. The clarity of the images will be graded according to the ICCE 2005 consensus regarding bowel preparation and prokinetics in capsule endoscopy.

Conditions

• Slow Transit

Interventions

Type	Name	Description
OTHER	Sham Feeding of Bacon Bits	Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
OTHER	Placebo	Participants will not be asked to chew bacon bits

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-11-16
• Completion: 2017-05-01
• First posted: 2015-02-02
• Last updated: 2017-12-27

Locations

1 site across 1 country: Canada