Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives
2026年5月18日 更新者：Joseph Spataro
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
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
57
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Virginia
-
Richmond、Virginia、美国、23249
- Central Virginia VA Health Care System
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental: Food Kit with Laxatives (Happy Colon Foods)
Patients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions.
|
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
|
|
有源比较器：Control: Standard GoLYTELY Split-Dose Prep
Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy.
|
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient acceptance/satisfaction
大体时间：Periprocedural
|
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
|
Periprocedural
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of bowel preparation
大体时间：During colonoscopy (single procedure)
|
Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9.
Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups.
|
During colonoscopy (single procedure)
|
|
Patient-reported symptoms during bowel preparation
大体时间：Periprocedural
|
Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing).
|
Periprocedural
|
|
Adverse events during bowel preparation
大体时间：Periprocedural
|
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
|
Periprocedural
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Irrigation and suction time
大体时间：Periprocedural
|
Time spent on irrigation and suction during colonoscopy, measured in minutes
|
Periprocedural
|
|
Colonoscopy withdrawal time
大体时间：Periprocedural
|
Time from cecum to scope removal, measured in minutes
|
Periprocedural
|
|
Total colonoscopy procedure time
大体时间：Periprocedural
|
Total time from scope insertion to removal, measured in minutes
|
Periprocedural
|
|
Cecal intubation rate
大体时间：Periprocedural
|
Proportion of subjects with successful cecal intubation
|
Periprocedural
|
|
Adenoma detection rate
大体时间：Periprocedural
|
Proportion of subjects with at least one adenoma detected
|
Periprocedural
|
|
Adenomas per colonoscopy
大体时间：Periprocedural
|
Mean number of adenomas detected per colonoscopy
|
Periprocedural
|
|
Presence of diverticulosis
大体时间：Periprocedural
|
Proportion of subjects with diverticulosis identified during colonoscopy
|
Periprocedural
|
|
Time to first bowel movement
大体时间：Periprocedural
|
Interval from ingestion of bowel preparation laxative to the first bowel movement
|
Periprocedural
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
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- Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月1日
初级完成 (实际的)
2025年6月24日
研究完成 (实际的)
2025年6月24日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月26日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism.
Aggregate results will be disseminated through presentations and peer-reviewed publications.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.