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Completed

NCT Number: NCT01241825

The Effect of Chewing Gum on Small Bowel Transit Time

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.

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Key information

Conditions

Bowel Transit Times

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trident sugarless chewing gum.

Other

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.

One control group (these do not chew gum).

Other

The control group will not chew chewing gum while undergoing capsule endoscopy

Primary outcomes

  1. Small bowel transit time

    Time frame: 6 hours

Secondary outcomes

  1. Gastric transit time, cecal completion rate

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 16, 2010
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.