The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time (CGCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Transit Time; Small-bowel Transit Time
• Intervention / Treatment: Other: Chewing Gum; Other: Control

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Placebo Comparator: Control; The control group will not chew chewing gum while undergoing capsule endoscopy.	Other: Control; The control group will not chew chewing gum while undergoing capsule endoscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Bin Lv, M.D., First Affiliated Hospital of Zhejiang Chinese Medical University

Publications and helpful links

General Publications

• Huang L, Hu Y, Chen F, Liu S, Lu B. Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study. Front Med (Lausanne). 2021 Feb 15;8:605393. doi: 10.3389/fmed.2021.605393. eCollection 2021. Erratum In: Front Med (Lausanne). 2022 Jan 24;8:805642.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CG-HuY-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data sharing will be consider after study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No