Simethicone-containing bowel prep for colon cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial evaluates the efficacy and tolerability of a simethicone-containing evacuating solution for patients undergoing screening colonoscopy after a positive fecal occult blood test. Eligible participants are adults aged 50-69 who participated in a colorectal cancer early detection program and are scheduled for colonoscopy at Hospital Clínic de Barcelona. The study uses Clensia and Citrafleet as the bowel-cleansing interventions and excludes individuals with severe renal failure, advanced heart failure, recent colonoscopy, significant functional impairment with certain constellations, major mental disorders, or language barriers. Primary outcomes focus on bowel cleanliness and tolerability of the preparation in this specific screening context, with informed consent required.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Maria Pellisé
• Email: MPELLISE@clinic.cat
• Phone: +34 932275400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.