Colorectal Cancer Early DetectionPhase 4CLEAN+NCT07696793
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy
A Phase 4 study testing Clensia® and Citrafleet® in people with Colorectal Cancer Early Detection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colorectal Cancer Early Detection
- What is being tested?
- Clensia® and Citrafleet®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteSpain
- Study dates
- 18 May 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Maria Pellisé, MPELLISE@clinic.cat
Maria Pellisé
About this study
Official title: 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.
- Conditions
- Colorectal Cancer Early Detection
- Being tested
- Clensia®, Citrafleet®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clensia®Drug
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.
Citrafleet®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clensia® | Experimental | 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. Receives: Drug: Clensia® |
| Citrafleet® | Experimental | 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. Receives: Drug: Citrafleet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: week 2 (Colonoscopy visit)
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 2 (Colonoscopy visit) and week 4 (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start18 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Early DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696793
- Sponsor's protocol ID
- 2025-523748-11-00
- Other IDs
- 2025
- Acronym
- CLEAN+
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
- ClinicalTrials.gov ID
- NCT07696793
- Acronym / sponsor ID
- CLEAN+ / 2025-523748-11-00
- Conditions
- Colorectal Cancer Early Detection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 818 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clensia® | Experimental | Drug: 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. |
| Citrafleet® | Experimental | Drug: 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. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Clensia® |
| 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. | Drug | Citrafleet® |
Primary outcome
Adenoma detection rate
Time frame: 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)).
17 secondary outcomes
Lesion detection rate
Time frame: week 2 (Colonoscopy visit)
Adenomas per colonoscopy
Time frame: week 2 (Colonoscopy visit)
Presence of foam
Time frame: week 2 (Colonoscopy visit)
Presence of bubbles
Time frame: week 2 (Colonoscopy visit)
Quality of colon cleansing
Time frame: week 2 (Colonoscopy visit)
Need for washing tools during colonoscopy
Time frame: week 2 (Colonoscopy visit)
Cecal intubation rate
Time frame: week 2 (Colonoscopy visit)
Cecal intubation time
Time frame: week 2 (Colonoscopy visit)
Endoscope removal time
Time frame: week 2 (Colonoscopy visit)
Requires repeat colonoscopy due to poor preparation
Time frame: week 2 (Colonoscopy visit)
Adherence to the intake of the preparation
Time frame: week 2 (Colonoscopy visit)
Ease of taking the preparation
Time frame: week 2 (Colonoscopy visit)
Palatability of the preparation
Time frame: week 2 (Colonoscopy visit)
Willingness to repeat the intake of the preparation
Time frame: week 2 (Colonoscopy visit)
Overall satisfaction with the intake of the preparation
Time frame: week 2 (Colonoscopy visit)
Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
Time frame: week 2 (Colonoscopy visit)
Rate of adverse events
Time frame: week 2 (Colonoscopy visit) and week 4 (visit 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clensia® and Citrafleet® in people with Colorectal Cancer Early Detection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Pellisé (+34 932275400, MPELLISE@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: week 2 (Colonoscopy visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.