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The Effect of Chewing Gum on Small Bowel Transit Time

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ClinicalTrials.gov Identifier: NCT01241825
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bowel Transit Times Other: Trident sugarless chewing gum. Other: One control group (these do not chew gum). Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1.
The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.
Other: Trident sugarless chewing gum.
Patients will be randomly divided into 2 groups, one subject group (these chew gum) and one control group (these do not chew gum). The subjects will have to chew Trident sugarless chewing gum for 20-30 minutes every 2 hours, all together 4 times at t=0 h, t=2, t=4 and t=6 h.
Placebo Comparator: 2.
The control group will not chew chewing gum while undergoing capsule endoscopy.
Other: One control group (these do not chew gum).
The control group will not chew chewing gum while undergoing capsule endoscopy



Primary Outcome Measures :
  1. Small bowel transit time [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Gastric transit time, cecal completion rate [ Time Frame: 6 hours ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241825


Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Robert A. Enns, Dr. University of British Columbia
Study Director: Eric Lam, Dr. University of British Columbia
Study Director: Jennifer Telford, Dr. University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01241825     History of Changes
Other Study ID Numbers: H10-01726
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by University of British Columbia:
capsule endoscopy
chewing gum
small bowel transit time