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治験 NCT07320989（対象：大腸癌検診）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メリーランド大学ボルティモア校Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy 100 予防
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07320989 は 介入研究 臨床試験 で、大腸癌検診 に関するものです。現在は 募集準備中 で、2025年12月21日 に開始予定です。100 名の参加者 の募集が計画されています。この試験は メリーランド大学ボルティモア校 によって主導され、2025年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月6日 です。
概要
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...もっと見る
詳細説明
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...もっと見る
公式タイトル
Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial
疾患名
大腸癌検診刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- HP-00115658
NCT番号
開始日
2025-12-21
最終更新日
2026-01-06
終了予定日
2025-12-31
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
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
主目的
予防
割付方法
無作為化
介入モデル
ファクトリアル割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Chewing 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...もっと見る | 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...もっと見る 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. |
実薬対照薬Standard 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. |
実験的Chewing 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...もっと見る | 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...もっと見る 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. |
実薬対照薬Standard 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. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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). |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
45 Years
対象性別
全て
- 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
メリーランド大学ボルティモア校責任者
Ekta Gupta, 主任研究者, Professor of Gastroenterology, University of Maryland, Baltimore
試験中央連絡先
連絡先: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 1カ国の場所
Maryland
UMMC Midtown - Outpatient Endoscopy Center, Towson, Maryland, 21204, United States
Ekta Gupta, MD, 連絡先, 410-698-6432, [email protected]