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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

November 12, 2010
November 16, 2010
September 30, 2014
September 2010
July 2012   (Final data collection date for primary outcome measure)
Small bowel transit time [ Time Frame: 6 hours ]
Same as current
Complete list of historical versions of study NCT01241825 on ClinicalTrials.gov Archive Site
Gastric transit time, cecal completion rate [ Time Frame: 6 hours ]
Same as current
Not Provided
Not Provided
 
The Effect of Chewing Gum on Small Bowel Transit Time
The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
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.
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Bowel Transit Times
  • 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.
  • Other: One control group (these do not chew gum).
    The control group will not chew chewing gum while undergoing capsule endoscopy
  • Active Comparator: 1.
    The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.
    Intervention: Other: Trident sugarless chewing gum.
  • Placebo Comparator: 2.
    The control group will not chew chewing gum while undergoing capsule endoscopy.
    Intervention: Other: One control group (these do not chew gum).
Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
Same as current
July 2013
July 2012   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01241825
H10-01726
No
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Not Provided
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
University of British Columbia
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP