The Effect of Chewing Gum on Small Bowel Transit Time

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01241825
First received: November 12, 2010
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention
Bowel Transit Times
Other: Trident sugarless chewing gum.
Other: One control group (these do not chew gum).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Small bowel transit time [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastric transit time, cecal completion rate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241825

Contacts
Contact: Sigrid Svarta 604-806-9440 sigrid.svarta@me.com

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Sigrid Svarta    604-806-9440    sigrid.svarta@me.com   
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
  More Information

No publications provided by University of British Columbia

Additional 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
Study First Received: November 12, 2010
Last Updated: July 30, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 29, 2014