The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.

Detailed Description
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The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).

Official Title
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The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study

Conditions
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Gastric Transit Time, Small-bowel Transit Time

Intervention / Treatment
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* Other: Chewing Gum
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years and <80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure. Exclusion Criteria: Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure. Patients, who have proven or suspected obstruction of the bowel. Patients, who have had prior small bowel and/or gastric surgery. Patients, who have a dysphagia prohibiting. Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chewing Gum<br>The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination. | Other: Chewing Gum<br>* Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.<br>|
| Placebo Comparator: Control<br>The control group will not chew chewing gum while undergoing capsule endoscopy. | Other: Control<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 |
| --- | --- | --- |
| gastric transit time | the time interval between the first gastric image and the first duodenal image | 1 hour | 
| small bowel transit time | The time interval between the first duodenal images and the first caecal image | 8 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate | the capsule reaching the caecum | 9 hours | 
| Diagnostic yield | the total number of positive (diagnostic and suspicious) findings | 9 hours | 
| Intervention rate | Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour | 1 hours |