Could a gas-busting ingredient in colonoscopy prep help spot more cancers?
NCT ID NCT07696793
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial compares two bowel-cleansing solutions used before screening colonoscopy for colorectal cancer. One contains simethicone, an anti-gas agent, while the other does not. The study aims to see if the simethicone-containing solution helps doctors detect more adenomas (precancerous polyps) during the procedure. Participants are adults aged 50–69 who have had a positive fecal occult blood test and are scheduled for a screening colonoscopy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clensia® (simethicone-containing bowel-cleansing solution)
- What this could lead to
- If it works, this could improve the detection of polyps and early-stage colorectal cancer during screening colonoscopies, potentially saving more lives through earlier diagnosis.
- What could go wrong
- This is a Phase 4 trial comparing two existing products, so the difference may be small. The main risk is discomfort from the bowel preparation itself, such as bloating or nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 818 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 69 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hospital Clínic de Barcelona
RECRUITINGBarcelona, Barcelona, 08036, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Can a new drug shrink advanced solid tumors?
- Can a new drug shrink tumors that resist standard care?
- A single blood draw to detect five cancers before symptoms appear?
- Can a new drug duo shrink Hard-to-Treat tumors?
- Could a simple mineral calm the Body's Post-Surgery fire?