The Effect of Chewing Gum on Small Bowel Transit Time

Not Applicable

Completed

• Conditions: Bowel Transit Times
• Interventions: Other: One control group (these do not chew gum).; Other: Trident sugarless chewing gum.

• Registration Number: NCT01241825
• Lead Sponsor: University of British Columbia

Brief Summary

The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.

Detailed Description

The subjects will include patients already referred to us for a capsule endoscopy (CE) in this unit. We have calculated how many patients we need from small bowel transit times from the last 100 patients who had a CE at our centre. We will include 122. These will be randomly divided into two groups. The patients (chew chewing gum) and the controls (do not chew chewing gum).

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• All out-patients > 19 years old presenting for capsule endoscopy

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Exclusion Criteria

• Patients on narcotics
• Patients on motility enhancing and/or slowing drugs should stop these at least 5 days prior to the procedure or be excluded from the study.
• Patients, who have proven or suspected obstruction of the bowel.
• Patients, who have had prior small bowel and/or gastric surgery.
• Patients with an ileostomy.
• Patients who have a known and/or have a history of swallowing disorder
• Patients with diabetes and/or hypo-/hyper- thyroidism
• Patients in whom the capsule become impacted at a stricture (these patients will be taken out of the study and given the necessary medical/surgical treatment).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.	One control group (these do not chew gum).	The control group will not chew chewing gum while undergoing capsule endoscopy.
1.	Trident sugarless chewing gum.	The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.

Primary Outcome Measures

Name	Time	Method
Small bowel transit time	6 hours

Secondary Outcome Measures

Name	Time	Method
Gastric transit time, cecal completion rate	6 hours

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada