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Taking people in SpainPhase 4

Comparing two bowel cleansing solutions before colonoscopy to screen for colorectal cancer

Compares Clensia and Citrafleet bowel preparations in adults having screening colonoscopy for colorectal cancer.

Key facts

Who runs it
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Where
Barcelona, SpainSee the site
Registry title
Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+
Status
Recruiting
Phase
Phase 4
People taking part
818 people, planned
Started
18 May 2026
Expected to end
19 Jan 2028
Type of study
Interventional
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men and women aged 49 to 70 who had a positive stool blood test in the colorectal cancer screening program and are scheduled for a screening colonoscopy at Hospital Clínic de Barcelona.

Age
49 to 70 years
Sex
Men and women
Disease stage
People in the colorectal cancer early detection program with a positive fecal occult blood test (≥20 μg Hb/g feces).
Earlier treatment
Cannot have had a colonoscopy within the last year.
Biomarker or test result
Positive fecal occult blood test (≥20 μg Hb/g feces).

Main reasons for not taking part

  • Severe kidney failure (grade IV or V) or heart failure (NYHA class III and IV)
  • Pregnancy or breastfeeding
  • Partial or total colon resection
  • Personal history of colorectal cancer, ulcerative colitis or Crohn's disease
  • Do not understand spoken or written Catalan or Spanish

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Men and women aged 49 to 70
  • 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 take part

  • Partial or total colon resection
  • Severe renal failure (grade IV or V) (Annex 5, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 6, NYHA Scale)
  • Hypersensitivity to the active ingredients of excipients
  • 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)
  • Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease)
  • 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)
  • Glucose-6-phosphate dehydrogenase deficiency
  • Hypermagnesemia
  • Rhabdomyolysis
  • Phenylketonuria
  • Pregnancy or breastfeeding
  • Colonoscopy within the last year
  • Barthel Index of <20 (Annex 4, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 7, Rome IV Criteria)
  • Do not understand spoken or written Catalan or Spanish

Where in Spain

  • Hospital Clinic de BarcelonaBarcelona, SpainTaking people

About the trial

What the trial wants to find out

To compare the clinical efficacy of Clensia® versus Citrafleet®, measured by adenoma detection rate, in patients undergoing colorectal cancer screening colonoscopy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+
Plain-language title
Comparing two bowel cleansing solutions before colonoscopy to screen for colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
21 September 2026