NCT07605897已完成4 期
A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population
Joseph Spataro1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年11月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
研究概览
简要总结
The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.
Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.
- Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
- Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
single-blinded endoscopist
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)
排除标准
- •Personal history of colorectal cancer
- •Inflammatory bowel disease
- •Prior colon resection
- •Antithrombotic therapy precluding polypectomy
- •Pregnancy
- •Hospitalization at the time of the scheduled procedure
- •Celiac disease (food kit contained gluten products)
- •Prior colonoscopy (cognitive bias)
- •Chronic kidney disease stage 3 or higher
- •Age 70 years or older.
研究者
Joseph Spataro
Staff Physician
Hunter Holmes Mcguire Veteran Affairs Medical Center
研究点 (1)
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