Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy

NCT07320989 | Active Not Recruiting

• 1 other identifier: HP-00115658
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the second leading cause of cancer deaths that could be prevented in the United States. Colonoscopy is the best test for finding and removing polyps before they turn into cancer. However, many people are hesitant to have a colonoscopy because of the bowel preparation. The preparation can be difficult to tolerate, with patients often struggling to finish it due to the taste, volume, or side effects like nausea and bloating. This can lead to incomplete procedures or discourage people from getting screened at all. Chewing sugar-free gum is a simple, low-cost, and safe intervention that may make the preparation process easier. One study from China found that chewing gum did not change the quality of bowel cleansing, but patients reported that they were more satisfied with the process. No U.S.-based studies have tested this strategy, and no prior research has looked at whether gum chewing has different effects in people using high-volume versus low-volume prep solutions. The investigators will randomize 160 participants to the stated intervention or control using computer-generated 1:1 randomization. Upon completing the study, the investigators will analyze the data. By studying gum chewing during bowel preparation, the investigators hope to find out whether this small change can make bowel prep more tolerable and encourage more patients to complete their colonoscopy. If successful, this approach could help more people get screened, leading to earlier detection and prevention of colorectal cancer in the community.

Conditions

Colon Cancer Screening

Keywords

Colonoscopy; Bowel Preparation; Chewing gum; Split-Dose PEG; Boston Bowel Preparation Scale; Patient Tolerance; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Bowel cleansing quality (BBPS total score)

  Boston Bowel Preparation Scale (0-9; sum of right, transverse, left colon segment scores) assessed by the blinded endoscopist. Higher scores indicate better cleansing.

  Day of colonoscopy (intra-procedure assessment, immediately prior to withdrawal).

Secondary Outcomes (9)

• Patient tolerance

  Day of colonoscopy (pre-procedure)

• Patient satisfaction

  Day of colonoscopy (pre-procedure)

• Prep completion rate

  Day of colonoscopy (pre-procedure)

• Willingness to repeat

  Day of colonoscopy (pre-procedure)

• Segmental Boston Bowel Preparation Scale (BPPS) Scores

  Day of colonoscopy (intra-procedure)

Study Arms (4)

Chewing Gum During Bowel Preparation (2L PEG-ELP)

EXPERIMENTAL

Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All participants will receive standard bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed according to clinical indication). The endoscopist performing the colonoscopy will remain blinded to group assignment.

Behavioral: Chewing Sugar-Free Gum During Bowel Preparation; Other: Standard Bowel Prep (2L PEG-ELP)

Standard Bowel Preparation 4L (No Gum)

ACTIVE COMPARATOR

Participants in the control arm will undergo standard split-dose bowel preparation (4L PEG) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.

Other: Standard Bowel Prep

Chewing Gum During 4L Bowel Preparation

EXPERIMENTAL

Arm Description: Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All participants will receive standard bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed according to clinical indication). The endoscopist performing the colonoscopy will remain blinded to group assignment.

Behavioral: Chewing Sugar-Free Gum During Bowel Preparation; Other: Standard Bowel Prep

Standard Bowel Preparation 2L PEG-ELP (No Gum)

ACTIVE COMPARATOR

Arm Description: Participants in the control arm will undergo standard split-dose bowel preparation (2L PEG + ascorbate) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.

Other: Standard Bowel Prep (2L PEG-ELP)

Interventions

Standard Bowel Prep OTHER

Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (4L PEG, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.

Chewing Gum During 4L Bowel Preparation; Standard Bowel Preparation 4L (No Gum)

Chewing Sugar-Free Gum During Bowel Preparation BEHAVIORAL

Participants randomized to the intervention arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before the first dose of split-dose polyethylene glycol (PEG) bowel preparation and again 30 minutes after completing the second dose. The gum-chewing activity is intended to improve tolerance and satisfaction with the bowel preparation process through cephalic-vagal stimulation ("sham feeding") without altering the underlying cleansing regimen.

Also known as: Chewing gum

Chewing Gum During 4L Bowel Preparation; Chewing Gum During Bowel Preparation (2L PEG-ELP)

Standard Bowel Prep (2L PEG-ELP) OTHER

Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.

Chewing Gum During Bowel Preparation (2L PEG-ELP); Standard Bowel Preparation 2L PEG-ELP (No Gum)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years
• Scheduled for elective outpatient colonoscopy
• Able to provide informed consent

You may not qualify if:

• Prior major abdominal surgery (excluding appendectomy or cholecystectomy)
• Pregnancy
• Cognitive impairment
• Ward of the state
• Known allergy to PEG or gum components
• Current use of GI prokinetics
• Known temporomandibular joint (TMJ) disorder or difficulty chewing/swallowing

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

UMMC Midtown - Outpatient Endoscopy Center

Towson, Maryland, 21204, United States

Location

Related Publications (5)

• Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the U.S. multi-society task force on colorectal cancer. Gastrointest Endosc. 2014 Oct;80(4):543-562. doi: 10.1016/j.gie.2014.08.002. No abstract available.

  PMID: 25220509 RESULT

• Gao C, Zou D, Wang W, Li Y, Han J, Su D, Qi X. Effect of chewing gum combined with WeChat-enhanced instruction on bowel preparation in constipated patients: a randomized-controlled trial. Gastroenterol Rep (Oxf). 2025 Apr 28;13:goaf034. doi: 10.1093/gastro/goaf034. eCollection 2025.

  PMID: 40297539 RESULT

• Guo T, et al. Chewing gum improves tolerance but not quality of bowel preparation: a systematic review and meta-analysis. World J Gastrointest Endosc. 2024;16(6):321-333.

  RESULT

• Atalay R, et al. Gum chewing improves bowel preparation quality for colonoscopy: a randomized trial. Turk J Gastroenterol. 2019;30(9):801-807.

  RESULT

• Zhang S, et al. Effect of chewing gum on bowel preparation before colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2019;62(7):874-881.

  RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: This is a prospective, endoscopist-blinded, randomized controlled trial with 1:1 allocation to gum chewing (intervention) or control (no gum) during bowel preparation. Participants in both groups undergo standard split-dose bowel prep with either high-volume (4L PEG) or low-volume (2L PEG + adjunct) regimens, prescribed per clinical indication.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 6, 2026
• Study Start: February 21, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)