Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
2026年7月6日 更新者：Fundacion Clinic per a la Recerca Biomédica
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
研究概览
研究类型
介入性
注册 (估计的)
818
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。
学习联系方式
- 姓名：Maria Pellisé
- 电话号码：+34 932275400
- 邮箱：MPELLISE@clinic.cat
研究联系人备份
- 姓名：Judit Pich
- 电话号码：2815 +34 932275400
- 邮箱：JPICH@recerca.clinic.cat
学习地点
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08036
- 招聘中
- Hospital Clinic de Barcelona
-
首席研究员：
- Maria Pellisé
-
接触：
- Maria Pellisé
- 邮箱：MPELLISE@clinic.cat
-
-
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:
- Men and women aged 50 to 69.
- Have participated in the early detection program for colorectal cancer.
- Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
- Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
- Signed informed consent form.
Exclusion Criteria:
- Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).
- Colonoscopy within the last year.
- Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).
- Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).
- Do not understand spoken or written Catalan or Spanish.
- Partial or total colon resection.
- Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
- Terminal illness or serious illness/disability that contraindicates subsequent colon study.
- Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
- Hypermagnesemia.
- Rhabdomyolysis.
- Phenylketonuria.
- Glucose-6-phosphate dehydrogenase deficiency.
- Hypersensitivity to the active ingredients of excipients.
- Pregnancy or breastfeeding.
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：诊断
- 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：Clensia®
Clensia®, powder for oral solution in sachet.
To be taken in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
|
Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
|
|
实验性的：Citrafleet®
Citrafleet®, powder for oral solution in sachet.
To be taken in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
|
Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
|
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 |
|---|---|---|
|
Adenoma detection rate
大体时间：week 2 (Colonoscopy visit)
|
Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).
|
week 2 (Colonoscopy visit)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lesion detection rate
大体时间：week 2 (Colonoscopy visit)
|
Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.
|
week 2 (Colonoscopy visit)
|
|
Adenomas per colonoscopy
大体时间：week 2 (Colonoscopy visit)
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
|
week 2 (Colonoscopy visit)
|
|
Presence of foam
大体时间：week 2 (Colonoscopy visit)
|
The presence of foam using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
|
week 2 (Colonoscopy visit)
|
|
Presence of bubbles
大体时间：week 2 (Colonoscopy visit)
|
The presence of bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
|
week 2 (Colonoscopy visit)
|
|
Quality of colon cleansing
大体时间：week 2 (Colonoscopy visit)
|
The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent).
A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.
|
week 2 (Colonoscopy visit)
|
|
Need for washing tools during colonoscopy
大体时间：week 2 (Colonoscopy visit)
|
Need for washing tools during colonoscopy.
The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted.
Likewise, the volume of simethicone used will be counted if it is considered necessary.
|
week 2 (Colonoscopy visit)
|
|
Cecal intubation rate
大体时间：week 2 (Colonoscopy visit)
|
Cecal intubation rate.
The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
|
week 2 (Colonoscopy visit)
|
|
Cecal intubation time
大体时间：week 2 (Colonoscopy visit)
|
Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
|
week 2 (Colonoscopy visit)
|
|
Endoscope removal time
大体时间：week 2 (Colonoscopy visit)
|
Endoscope removal time.
Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.
|
week 2 (Colonoscopy visit)
|
|
Requires repeat colonoscopy due to poor preparation
大体时间：week 2 (Colonoscopy visit)
|
Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale
|
week 2 (Colonoscopy visit)
|
|
Adherence to the intake of the preparation
大体时间：week 2 (Colonoscopy visit)
|
Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Ease of taking the preparation
大体时间：week 2 (Colonoscopy visit)
|
Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Palatability of the preparation
大体时间：week 2 (Colonoscopy visit)
|
Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Willingness to repeat the intake of the preparation
大体时间：week 2 (Colonoscopy visit)
|
Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Overall satisfaction with the intake of the preparation
大体时间：week 2 (Colonoscopy visit)
|
Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
大体时间：week 2 (Colonoscopy visit)
|
Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Data collection form).
|
week 2 (Colonoscopy visit)
|
|
Rate of adverse events
大体时间：week 2 (Colonoscopy visit) and week 4 (visit 2)
|
Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Tolerability and Satisfaction Questionnaire).
|
week 2 (Colonoscopy visit) and week 4 (visit 2)
|
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。
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)
2026年5月18日
初级完成 (估计的)
2028年5月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2025年9月26日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025-523748-11-00
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