Clinical trial NCT02353208: The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy
Official title: The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Slow Transit
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 122
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Small bowel transit time
timeFrame: 5 hours
Secondary outcomes:
measure: Gastric transit time
timeFrame: 1 hour
measure: Diagnostic yield of capsule endoscopy
timeFrame: 5 hours
measure: Completion examination rate
timeFrame: 8 hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GI Clinic, St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Robert Enns, M.D.
role: PRINCIPAL_INVESTIGATOR
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