Working… Menu

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02507037
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : March 18, 2016
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of procedure, patients' tolerance, and adverse events were also evaluated.

Condition or disease Intervention/treatment Phase
Bowel Preparation Scale Adenoma Detection Rate Dietary Supplement: gum+PEG Drug: polyethylene glycol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy: A Prospective Randomized Study
Study Start Date : July 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: gum+PEG
used 2L PEG+sugarless gum
Dietary Supplement: gum+PEG
chew sugarless gum

Placebo Comparator: PEG
only used 2L PEG
Drug: polyethylene glycol

Primary Outcome Measures :
  1. Boston Bowel Preparation Scale [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. number of patient tolerability [ Time Frame: 2 days ]
  2. number of patient willingness to repeat preparation [ Time Frame: 2 days ]
  3. Adenoma Detection Rate [ Time Frame: 2 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All adults (18-65) who were referred for outpatient colonoscopy.

Exclusion Criteria:

  • under 18 years or More than 65 years
  • previous abdominal surgery
  • major psychiatric disorders
  • pregnancy
  • presence of any contraindications for colonoscopy(eg, severe heart failure)
  • recent inadequate colonoscopy history

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital Identifier: NCT02507037     History of Changes
Other Study ID Numbers: Gum-1
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type