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Активно (без набиране) Не е приложимо NCT07320989

Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy

Не е приложима фаза (напр. обсервационно)
Заболявания: Colon Cancer Screening

Спонсор: University of Maryland, Baltimore

Налично на: БГ
Обобщение
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.
Описание
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. Study Objectives Primary Objective: To determine whether chewing sugar-free gum before and after split-dose bowel preparation improves bowel cleansing quality, measured by the Boston Bowel Preparation Scale (BBPS), compared with standard bowel preparation alone. Secondary Objectives: * To evaluate whether gum chewin
Кой може да участва
Inclusion Criteria: * Age 45-75 years * Scheduled for elective outpatient colonoscopy * Able to provide informed consent Exclusion Criteria: * 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
Интервенции
Chewing Sugar-Free Gum During Bowel Preparation
BEHAVIORAL
Standard Bowel Prep (2L PEG-ELP)
OTHER
Standard Bowel Prep
OTHER
Места на провеждане 1
САЩ (1)
UMMC Midtown - Outpatient Endoscopy Center
Towson , Maryland
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
45 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
21.02.2026
Крайна дата
30.12.2026
Регистрационен номер
NCT07320989
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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