Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bowel cleansing quality (BBPS total score)
研究概览
简要总结
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.
详细描述
Background and Rationale Colorectal cancer (CRC) remains the second leading cause of preventable cancer-related death in the United States, with approximately 150,000 new cases and 50,000 deaths annually. Colonoscopy is the gold-standard screening modality for CRC because it allows both detection and removal of precancerous lesions within the same procedure. However, the success of colonoscopy depends heavily on adequate bowel cleansing. Suboptimal bowel preparation can lead to missed lesions, prolonged procedure times, and incomplete examinations, ultimately reducing screening effectiveness.
One of the most common barriers to successful colonoscopy completion is the patient's difficulty tolerating bowel preparation. Poor tolerance-due to the taste, volume burden, nausea, bloating, or abdominal discomfort associated with polyethylene glycol (PEG)-based solutions-can result in incomplete ingestion of the prep solution and inadequate cleansing. These experiences often discourage patients from future screening, contributing to low adherence to recommended screening guidelines, particularly among underserved populations.
Chewing gum has been proposed as a simple and low-cost adjunct that could improve tolerance to bowel preparation. The act of chewing gum stimulates cephalic-vagal pathways through "sham feeding," promoting gastrointestinal motility without adding calories or affecting electrolyte balance. In postoperative and perioperative gastrointestinal contexts, gum chewing has been shown to accelerate recovery of bowel function. A few small randomized controlled trials (RCTs) have evaluated gum chewing during bowel preparation, with mixed results. The largest study, conducted in China (n=300), found no improvement in cleansing quality but higher patient satisfaction. Other smaller studies in Turkey and elsewhere suggested improved tolerability and, in some regimens, enhanced cleansing scores.
To date, no prospective, randomized, endoscopist-blinded studies in the United States have investigated the impact of gum chewing on bowel preparation quality and patient experience using modern split-dose PEG regimens. Furthermore, no study has systematically compared outcomes between high-volume (4L PEG) and low-volume (2L PEG + ascorbate) preparations-two regimens that differ in both cost and tolerability and are commonly prescribed based on insurance coverage and comorbidities.
This study aims to address this gap by testing whether a benign, widely available behavioral intervention-chewing sugar-free gum before and after split-dose bowel preparation-can improve tolerance, satisfaction, and potentially the quality of bowel cleansing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years
- •Scheduled for elective outpatient colonoscopy
- •Able to provide informed consent
排除标准
- •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
研究组 & 干预措施
Chewing Gum During Bowel Preparation (2L PEG-ELP)
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.
干预措施: Chewing Sugar-Free Gum During Bowel Preparation (Behavioral)
Chewing Gum During Bowel Preparation (2L PEG-ELP)
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.
干预措施: Standard Bowel Prep (2L PEG-ELP) (Other)
Standard Bowel Preparation 4L (No Gum)
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.
干预措施: Standard Bowel Prep (Other)
Chewing Gum During 4L Bowel Preparation
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.
干预措施: Chewing Sugar-Free Gum During Bowel Preparation (Behavioral)
Chewing Gum During 4L Bowel Preparation
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.
干预措施: Standard Bowel Prep (Other)
Standard Bowel Preparation 2L PEG-ELP (No Gum)
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.
干预措施: Standard Bowel Prep (2L PEG-ELP) (Other)
结局指标
主要结局
Bowel cleansing quality (BBPS total score)
时间窗: Day of colonoscopy (intra-procedure assessment, immediately prior to withdrawal).
Boston Bowel Preparation Scale (0-9; sum of right, transverse, left colon segment scores) assessed by the blinded endoscopist. Higher scores indicate better cleansing.
次要结局
- 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))
- Cecal intubation rate(Day of colonoscopy (intra-procedure))
- Adenoma detection rate (ADR)(Day of colonoscopy to 2 weeks post-procedure (to allow routine pathology posting))
- Procedure metrics(Day of colonoscopy)
- Adverse events(Day of colonoscopy)
研究者
Ekta Gupta
Professor of Gastroenterology
University of Maryland, Baltimore