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הניסוי הקליני NCT07320989 עבור בדיקת סרטן המעי הגס הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
אוניברסיטת מרילנד בבולטימורImpact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy 100 מניעה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07320989 הוא מחקר מסוג התערבותי עבור בדיקת סרטן המעי הגס, שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-21 בדצמבר 2025, במטרה לכלול 100 משתתפים. המחקר ינוהל על ידי אוניברסיטת מרילנד בבולטימור וצפוי להסתיים ב-31 בדצמבר 2025. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-6 בינואר 2026.
סיכום קצר
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...הצג עוד
תיאור מפורט
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...הצג עוד
כותרת רשמית
Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial
מצבים רפואיים
בדיקת סרטן המעי הגספרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:מזהי מחקר נוספים
- HP-00115658
מספר NCT
תחילת המחקר (בפועל)
2025-12-21
עדכון אחרון שפורסם
2026-01-06
סיום המחקר (מוערך)
2025-12-31
משתתפים (מתוכנן)
100
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מילות מפתח
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
מטרה ראשית
מניעה
הקצאת טיפול
אקראי
דגם מתערב
שיוך פקטוריאלי
עיוורון
יחיד
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיChewing 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...הצג עוד | 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...הצג עוד 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. |
משווה פעילStandard 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. |
ניסיChewing 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...הצג עוד | 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...הצג עוד 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. |
משווה פעילStandard 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. |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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). |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
45 Years
מגדרים מוערכים למחקר
הכל
- 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
אוניברסיטת מרילנד בבולטימורהגורם האחראי למחקר
Ekta Gupta, חוקר ראשי, Professor of Gastroenterology, University of Maryland, Baltimore
איש קשר מרכזי למחקר
איש קשר: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 מיקומי המחקר ב-1 מדינות
Maryland
UMMC Midtown - Outpatient Endoscopy Center, Towson, Maryland, 21204, United States
Ekta Gupta, MD, איש קשר, 410-698-6432, [email protected]