The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study
Phase: NA
Conditions: Gastric Transit Time, Small-bowel Transit Time
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Title Page 
 
 
 
 
 
Official title: Clinical Study Protocol 
 
NCT number: NCT03815136 
 
Date: Oct 31, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 
 
Study title: The Effectiveness of Improved Use of Chewing Gum in Influencing 
Capsule Endoscopy Transit Time - a Prospective Randomized, Controlled Pilot 
Study. 
Approval date: Oct 25, 2018 
 
Study description: 
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 subjects will include patients who need to a capsule 
endoscopy (CE) in this unit. We will include 200 patients who had a CE at our centre 
based on the gastric transit times. These will be randomly divided into two groups. 
The patients (chew chewing gum) and the controls (do not chew chewing gum). 
(Capsule endoscopy type: PillCam SB2) 
Study Time: 
Start: January 31, 2019 
Primary Completion: June 30, 2019 
Study Completion: July 31, 2019 
 
Eligibility criteria:  
Inclusion Criteria: Patients aged ≥16 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 5 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. 
Arms and Interventions: 
Arms:  
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. 
Control：The control group will not chew chewing gum while undergoing capsule 
endoscopy. 
 
Assigned Interventions: 
Chewing Gum: Patients of chewing gum 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. 
 
Participants’ information: Sex, Age, BMI, Examination reason. 
 
Outcomes: 
Primary Outcome Measure: 
Gastric transit time (GTT): The time interval between the first gastric image and the 
first duodenal image. 
Small bowel transit time (SBTT): The time interval between the first duodenal images 
and the first caecal image. 
 
Secondary Outcome Measure: 
Completion rate (CR): The capsule reaching the caecum. 
Diagnostic yield (DY): The total number of positive (diagnostic and suspicious) 
findings. 
Intervention rate: Gastroscopy intervention after capsule endoscopy not through 
pylorus within 1hour. 
 
Randomization:  
Computer-generated random numbers. 
 
Statistical analysis: 
Descriptive statistics were used for the baseline characteristics of the participants. 
Continuous variables were expressed as mean ± SD, and compared using the Student 
t-test, while categorical variables were expressed as percentages and counts, and 
compared using the χ2 test for categorical variables.