The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

NCT03815136 | Completed DMC

• 1 other identifier: CG-HuY-1901
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Transit Time; Small-bowel Transit Time

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Completion rate

  9 hours

• Diagnostic yield

  9 hours

• Intervention rate

  1 hours

Study Arms (2)

Chewing Gum

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

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.

Chewing Gum

Control OTHER

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

Control

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years and \<80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

• 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.

  PMID: 33681244 DERIVED

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bin Lv, M.D.

  First Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 24, 2019
• Study Start: January 20, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

CN (1)