The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-07-31

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.

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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).

Conditions

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Gastric Transit Time Small-bowel Transit Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.

Study Groups

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Chewing Gum

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.

Group Type ACTIVE_COMPARATOR

Chewing Gum

Intervention Type OTHER

Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Chewing Gum

Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.

Intervention Type OTHER

Control

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

Intervention Type OTHER

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No