The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

Not Applicable

Completed

• Conditions: Gastric Transit Time; Small-bowel Transit Time
• Interventions: Other: Control; Other: Chewing Gum

• Registration Number: NCT03815136
• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary

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

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).

Study Timeline

• Study Start: 2019-01-20
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group will not chew chewing gum while undergoing capsule endoscopy.
Chewing Gum	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.

Primary Outcome Measures

Name	Time	Method
gastric transit time	1 hour	the time interval between the first gastric image and the first duodenal image
small bowel transit time	8 hour	The time interval between the first duodenal images and the first caecal image

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China