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.
調査の概要
研究の種類
介入
入学 (推定)
818
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Maria Pellisé
- 電話番号：+34 932275400
- メール：MPELLISE@clinic.cat
研究連絡先のバックアップ
- 名前：Judit Pich
- 電話番号：2815 +34 932275400
- メール：JPICH@recerca.clinic.cat
研究場所
-
-
Barcelona
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Barcelona、Barcelona、スペイン、08036
- 募集
- Hospital Clinic de Barcelona
-
主任研究者：
- Maria Pellisé
-
コンタクト：
- Maria Pellisé
- メール：MPELLISE@clinic.cat
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adenoma detection rate
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lesion detection rate
時間枠：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
時間枠：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
時間枠：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)
|
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Presence of bubbles
時間枠：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
時間枠：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)
|
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Need for washing tools during colonoscopy
時間枠：week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
|
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Cecal intubation rate
時間枠：week 2 (Colonoscopy visit)
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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)
|
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Cecal intubation time
時間枠：week 2 (Colonoscopy visit)
|
Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
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week 2 (Colonoscopy visit)
|
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Endoscope removal time
時間枠：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)
|
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Requires repeat colonoscopy due to poor preparation
時間枠：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
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week 2 (Colonoscopy visit)
|
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Adherence to the intake of the preparation
時間枠：week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
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Ease of taking the preparation
時間枠：week 2 (Colonoscopy visit)
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Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
|
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Palatability of the preparation
時間枠：week 2 (Colonoscopy visit)
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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)
|
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Willingness to repeat the intake of the preparation
時間枠：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)
|
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Overall satisfaction with the intake of the preparation
時間枠：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)
|
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Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
時間枠：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)
|
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Rate of adverse events
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月18日
一次修了 (推定)
2028年5月1日
研究の完了 (推定)
2028年5月1日
試験登録日
最初に提出
2025年9月26日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月10日
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025-523748-11-00
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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