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

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status: Completed

Conditions: Gastric Transit Time; Small-bowel Transit Time

Treatments: Other: Control; Other: Chewing Gum

Study type: Interventional

Funder types: Other

Identifiers

NCT03815136

CG-HuY-1901

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Chewing Gum

Active Comparator group

Description:

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.

Treatment:

Other: Chewing Gum

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control