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

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Die klinische Studie NCT07320989 ist eine interventionsstudie zur Untersuchung von Darmkrebsvorsorge und hat den Status noch nicht rekrutierend. Der Start ist für 21. Dezember 2025 geplant, bis 100 Teilnehmer aufgenommen werden. Durchgeführt von Universität von Maryland, Baltimore wird der Abschluss für 31. Dezember 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. Januar 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Darmkrebsvorsorge
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • HP-00115658
NCT-Nummer
NCT07320989
Studienbeginn (tatsächlich)
2025-12-21
Zuletzt aktualisiert
2026-01-06
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
100
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Faktoriell
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellChewing 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...Mehr anzeigen
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...Mehr anzeigen
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.
Aktives VergleichspräparatStandard 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.
ExperimentellChewing 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...Mehr anzeigen
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...Mehr anzeigen
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.
Aktives VergleichspräparatStandard 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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).
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
45 Years
Zugelassene Geschlechter
Alle
  • 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 logoUniversität von Maryland, Baltimore
Verantwortliche Partei
Ekta Gupta, Hauptprüfer, Professor of Gastroenterology, University of Maryland, Baltimore
Zentrale Studienkontakte
Kontakt: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 Studienstandorte in 1 Ländern

Maryland

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