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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Slow Transit

Intervention / Treatment
-----------------
* Other: Sham Feeding of Bacon Bits
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-patients, 19 years or older referred to St. Paul's Hospital for capsule endoscopy Exclusion Criteria: In-patients will be excluded Patients who have been taking taken medications that affect your bowel movement in the five days prior to the procedure Patients who are vegetarian or have dietary restrictions that do not allow bacon/pork products. Patients, who have proven or suspected obstruction of the bowel. Patients, who have had prior small bowel and/or stomach surgery. Patients who have a known and/or have a history suggestive of a swallowing disorder Patients with complicated diabetes diabetes with associated complications (bleeding in eyes, kidney disease, or numbness/tingling in hands/feet) Patient who have thyroid problem that is not being treated (for example, hypothyroid but not taking supplement) Patients who are pregnant, prisoners or an institutionalized individuals Patients whose capsule camera is placed using a traditional scope (instead of swallowing the capsule camera)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sham Feeding of Bacon Bits<br>In addition to the standard procedure, subjects will be asked to perform sham feeding on two occasions: 1) Immediately after having swallowed the capsule and 2) One hour after having swallowed the capsule. Sham feeding will be performed as follows: The patients will be asked to chew 10 times on a piece of bacon over a period of 30 seconds, prior to spitting saliva and bacon into a container. This will be repeated 10 times at one minute intervals. The patient will then complete the capsule study as per the standard procedure. Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada. | Other: Sham Feeding of Bacon Bits<br>* Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.<br>* Other names: Bacon bits;|
| Placebo Comparator: Placebo<br>The control group will not chew bacon bits while undergoing capsule endoscopy. | Other: Placebo<br>* Participants will not be asked to chew bacon bits<br>* Other names: Control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel transit time | To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT) | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric transit time | To investigate whether sham feeding shortens gastric transit time (GTT) | 1 hour | 
| Diagnostic yield of capsule endoscopy | To investigate whether sham feeding alters clarity of the capsule endoscopy images. | 5 hours | 
| Completion examination rate | To investigate whether sham feeding using bacon increases the completion examination rate (CER) | 8 hours |