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

NCT02353208 | Completed

• 1 other identifier: H14-03443
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Slow Transit

Outcome Measures

Primary Outcomes (1)

• Small bowel transit time

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

  5 hours

Secondary Outcomes (3)

• Gastric transit time

  1 hour

• Diagnostic yield of capsule endoscopy

  5 hours

• Completion examination rate

  8 hours

Study Arms (2)

Sham Feeding of Bacon Bits

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

The control group will not chew bacon bits while undergoing capsule endoscopy.

Other: Placebo

Interventions

Sham Feeding of Bacon Bits OTHER

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

Also known as: Bacon bits

Sham Feeding of Bacon Bits

Placebo OTHER

Participants will not be asked to chew bacon bits

Also known as: Control

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-patients, 19 years or older referred to St. Paul's Hospital for capsule endoscopy

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (27)

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Study Officials

• Robert Enns, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: November 16, 2016
• Study Completion: May 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

CA (1)