The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy
NCT ID: NCT02353208
Last Updated: 2017-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2015-01-31
2017-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Sham Feeding of Bacon Bits
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.
Sham Feeding of Bacon Bits
Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
Placebo
The control group will not chew bacon bits while undergoing capsule endoscopy.
Placebo
Participants will not be asked to chew bacon bits
Interventions
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Sham Feeding of Bacon Bits
Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
Placebo
Participants will not be asked to chew bacon bits
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
19 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Robert Enns
Clinical Associate Professor
Principal Investigators
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Robert Enns, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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References
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Other Identifiers
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H14-03443
Identifier Type: -
Identifier Source: org_study_id