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

Slow Transit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353208
• Other study ID #: H14-03443
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: December 22, 2017
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2017
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Slow Transit

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	GI Clinic, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small bowel transit time	To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT)	5 hours
Secondary	Gastric transit time	To investigate whether sham feeding shortens gastric transit time (GTT)	1 hour
Secondary	Diagnostic yield of capsule endoscopy	To investigate whether sham feeding alters clarity of the capsule endoscopy images.	5 hours
Secondary	Completion examination rate	To investigate whether sham feeding using bacon increases the completion examination rate (CER)	8 hours