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

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L'essai clinique NCT07320989 est une étude interventionnel pour Dépistage du cancer du côlon. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 21 décembre 2025, avec un objectif de 100 participants. Dirigée par l'Université du Maryland à Baltimore, l'étude devrait être terminée d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 6 janvier 2026.
Résumé succinct
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...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel

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

Pathologies
Dépistage du cancer du côlon
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • HP-00115658
Numéro NCT
NCT07320989
Date de début (réel)
2025-12-21
Dernière mise à jour publiée
2026-01-06
Date de fin (estimée)
2025-12-31
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
Objectif principal
Prévention
Méthode d'allocation
Randomisé
Modèle d'intervention
Factoriel
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalChewing 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...Afficher plus
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...Afficher plus
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.
Comparateur actifStandard 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.
ExpérimentalChewing 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...Afficher plus
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...Afficher plus
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.
Comparateur actifStandard 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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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).
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
45 Years
Sexes éligibles
Tous
  • 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 logoUniversité du Maryland à Baltimore
Partie responsable de l'étude
Ekta Gupta, Investigateur principal, Professor of Gastroenterology, University of Maryland, Baltimore
Contact central de l'étude
Contact: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 Centres de l'étude dans 1 pays

Maryland

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