Chewing Gum for Colon Cancer Screening

EG
Overseen ByEkta Gupta, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am scheduled for a planned outpatient colonoscopy.
Able to provide informed consent
I am between 45 and 75 years old.

Exclusion Criteria

Pregnancy
I am currently taking medication to help my digestive system move food.
Cognitive impairment
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Bowel Preparation

Participants undergo split-dose bowel preparation with or without chewing gum

24 hours
1 visit (in-person)

Colonoscopy Procedure

Participants undergo colonoscopy to assess bowel cleansing quality and other metrics

1 day
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and outcomes post-procedure

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Chewing Sugar-Free Gum

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Chewing Gum During Bowel Preparation (2L PEG-ELP)Experimental Treatment2 Interventions
Group II: Chewing Gum During 4L Bowel PreparationExperimental Treatment2 Interventions
Group III: Standard Bowel Preparation 4L (No Gum)Active Control1 Intervention
Group IV: Standard Bowel Preparation 2L PEG-ELP (No Gum)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+