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Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy 100 Prevenção

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O estudo clínico NCT07320989 é um estudo intervencionista para Rastreamento do câncer de cólon. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 21 de dezembro de 2025, com o objetivo de incluir 100 participantes. Coordenado por a Universidade de Maryland, Baltimore e deve ser concluído em 31 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 6 de janeiro de 2026.
Resumo
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 effect...Mostrar mais
Descrição detalhada
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 adeq...Mostrar mais
Título oficial

Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial

Condições médicas
Rastreamento do câncer de cólon
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • HP-00115658
Número NCT
NCT07320989
Data de início (real)
2025-12-21
Última atualização postada
2026-01-06
Data de conclusão (estimada)
2025-12-31
Inscrição (estimada)
100
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Fatorial
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalChewing 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 receiv...Mostrar mais
Chewing Sugar-Free Gum During Bowel Preparation
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 fe...Mostrar mais
Standard Bowel Prep (2L PEG-ELP)
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.
Comparador ativoStandard 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.
Standard Bowel Prep
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.
ExperimentalChewing 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 particip...Mostrar mais
Chewing Sugar-Free Gum During Bowel Preparation
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 fe...Mostrar mais
Standard Bowel Prep
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.
Comparador ativoStandard 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.
Standard Bowel Prep (2L PEG-ELP)
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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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).
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Patient tolerance
Global tolerance/symptom score (Likert or VAS) for nausea, bloating, cramps, and overall ease of prep recorded during routine pre-procedure nursing intake.
Day of colonoscopy (pre-procedure)
Patient satisfaction
Single-item satisfaction rating (Likert) with the bowel preparation process, recorded by nursing staff.
Day of colonoscopy (pre-procedure)
Prep completion rate
Proportion completing 100% of prescribed split-dose regimen vs partial/unknown, per intake documentation.
Day of colonoscopy (pre-procedure)
Willingness to repeat
Willingness to repeat the same bowel prep in the future (yes/no or Likert).
Day of colonoscopy (pre-procedure)
Segmental Boston Bowel Preparation Scale (BPPS) Scores
Right, transverse, and left colon BBPS segment scores. 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)
Cecal intubation rate
Successful cecal intubation (yes/no) per standard endoscopy report.
Day of colonoscopy (intra-procedure)
Adenoma detection rate (ADR)
Proportion of colonoscopies with ≥1 histologically confirmed adenoma (if pathology recorded as part of usual care).
Day of colonoscopy to 2 weeks post-procedure (to allow routine pathology posting)
Procedure metrics
Withdrawal time and total procedure duration (minutes).
Day of colonoscopy
Adverse events
Immediate procedure-day AEs (e.g., gum-related issues reported at intake; standard colonoscopy AEs captured in recovery notes).
Day of colonoscopy
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
45 Years
Sexos elegíveis
Todos
  • Age 45-75 years
  • Scheduled for elective outpatient colonoscopy
  • Able to provide informed consent

  • 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
University of Maryland, Baltimore logoUniversidade de Maryland, Baltimore
Responsável pelo estudo
Ekta Gupta, Investigador principal, Professor of Gastroenterology, University of Maryland, Baltimore
Contato central do estudo
Contato: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 Locais do estudo em 1 países

Maryland

UMMC Midtown - Outpatient Endoscopy Center, Towson, Maryland, 21204, United States
Ekta Gupta, MD, Contato, 410-698-6432, [email protected]