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Completed

NCT Number: NCT02353208

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

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.

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Key information

Conditions

Slow Transit

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sham Feeding of Bacon Bits

Other

Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.

Other names: Bacon bits

Placebo

Other

Participants will not be asked to chew bacon bits

Other names: Control

Primary outcomes

  1. Small bowel transit time

    Time frame: 5 hours

    To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 2, 2015
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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