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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353208
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Enns, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Slow Transit Other: Sham Feeding of Bacon Bits Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: a Prospective Randomized Trial
Study Start Date : January 2015
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: 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.

Other: Sham Feeding of Bacon Bits
Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
Other Name: Bacon bits

Placebo Comparator: Placebo
The control group will not chew bacon bits while undergoing capsule endoscopy.
Other: Placebo
Participants will not be asked to chew bacon bits
Other Name: Control




Primary Outcome Measures :
  1. Small bowel transit time [ Time Frame: 5 hours ]
    To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT)


Secondary Outcome Measures :
  1. Gastric transit time [ Time Frame: 1 hour ]
    To investigate whether sham feeding shortens gastric transit time (GTT)

  2. Diagnostic yield of capsule endoscopy [ Time Frame: 5 hours ]
    To investigate whether sham feeding alters clarity of the capsule endoscopy images.

  3. Completion examination rate [ Time Frame: 8 hours ]
    To investigate whether sham feeding using bacon increases the completion examination rate (CER)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353208


Locations
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Canada, British Columbia
GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Robert Enns, M.D. University of British Columbia
Publications:

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Responsible Party: Robert Enns, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02353208    
Other Study ID Numbers: H14-03443
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017