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

December 22, 2017 updated by: Robert Enns, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • GI Clinic, St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Robert Enns, M.D., University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • H14-03443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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