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Completed

NCT Number: NCT03815136

The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

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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Key information

Conditions

Gastric Transit Time Small-bowel Transit Time

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chewing Gum

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

Other

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

Primary outcomes

  1. gastric transit time

    Time frame: 1 hour

    the time interval between the first gastric image and the first duodenal image

  2. small bowel transit time

    Time frame: 8 hour

    The time interval between the first duodenal images and the first caecal image

Secondary outcomes

  1. Completion rate

    Time frame: 9 hours

    the capsule reaching the caecum

  2. Diagnostic yield

    Time frame: 9 hours

    the total number of positive (diagnostic and suspicious) findings

  3. Intervention rate

    Time frame: 1 hours

    Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Acronym: CGCE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.