The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Small bowel transit time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
1.
The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.
Intervention: Trident sugarless chewing gum. (Other)
2.
The control group will not chew chewing gum while undergoing capsule endoscopy.
Intervention: One control group (these do not chew gum). (Other)
Outcomes
Primary Outcomes
Small bowel transit time
Time Frame: 6 hours
Secondary Outcomes
- Gastric transit time, cecal completion rate(6 hours)