Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Early Detection
• Intervention / Treatment: Drug: Clensia®; Drug: Citrafleet®

• Study Type: Interventional
• Enrollment (Estimated): 818
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria Pellisé; Phone Number: +34 932275400; Email: MPELLISE@clinic.cat
• Study Contact Backup: Name: Judit Pich; Phone Number: 2815 +34 932275400; Email: JPICH@recerca.clinic.cat

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Recruiting
      • Hospital Clinic de Barcelona
      • Principal Investigator: Maria Pellisé
      • Contact: Maria Pellisé; Email: MPELLISE@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women aged 50 to 69.
2. Have participated in the early detection program for colorectal cancer.
3. Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
4. Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
5. Signed informed consent form.

Exclusion Criteria:

1. 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).
2. Colonoscopy within the last year.
3. 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).
4. 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).
5. Do not understand spoken or written Catalan or Spanish.
6. Partial or total colon resection.
7. Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
8. Terminal illness or serious illness/disability that contraindicates subsequent colon study.
9. Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
10. Hypermagnesemia.
11. Rhabdomyolysis.
12. Phenylketonuria.
13. Glucose-6-phosphate dehydrogenase deficiency.
14. Hypersensitivity to the active ingredients of excipients.
15. Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Clensia®; 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.
Experimental: 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.	Drug: Citrafleet®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion detection rate	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-523748-11-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No