The Effect of Chewing Gum on Small Bowel Transit Time

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Bowel Transit Times

Intervention / Treatment
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* Other: Trident sugarless chewing gum.
* Other: One control group (these do not chew gum).


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.<br>The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. | Other: Trident sugarless chewing gum.<br>* 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.<br>|
| Placebo Comparator: 2.<br>The control group will not chew chewing gum while undergoing capsule endoscopy. | Other: One control group (these do not chew gum).<br>* The control group will not chew chewing gum while undergoing capsule endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel transit time |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric transit time, cecal completion rate |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsule endoscopy, chewing gum, small bowel transit time