Testing gut microbiome for colorectal cancer screening
Official title: A Non-invasive Gut Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06588166 · Data updated 2026-11-12
This study is trying to see if testing the gut bacteria of people aged 50-74 who have a positive stool test can help find colorectal cancer earlier and reduce the need for unnecessary colonoscopies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years to 74 Years |
| Sex | All |
| Enrollment | 1006 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | November 29, 2024 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06588166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 50-74 who are part of the national CRC screening program and have a positive FIT result.
✕Probably not a fit
Patients who are unfit for colonoscopy or have other oncological conditions or severe gastrointestinal diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop a diagnostic tool based on gut microbiome testing to identify colorectal cancer (CRC) and advanced colorectal adenomas. It focuses on patients aged 50-74 who are participating in the national CRC screening program and have tested positive for fecal immunochemical testing (FIT). The study leverages evidence that specific alterations in the gut microbiome are associated with CRC, aiming to improve diagnostic accuracy and reduce unnecessary colonoscopies. By identifying microbial signatures that differentiate CRC patients from healthy individuals, the study seeks to enhance early detection methods.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and non-invasive screening for colorectal cancer, potentially reducing mortality rates.
How similar studies have gone: While the approach of using microbiome-based biomarkers for CRC screening is supported by emerging evidence, this specific study represents a novel application in clinical practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients participating in the national CRC screening program (50-74 years old) * Positivity to the FIT; * Ability to provide written informed consent and to be compliant with the study procedures Exclusion Criteria: * Patients unfit for colonoscopy; * Other oncological conditions; * Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease); * Antibiotics,proton pump inhibitors or probiotics within 4 weeks prior to enrollment.
Where it's running
-
Fondazione Policlinico Agostino Gemelli, IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Gianluca Ianiro, MD, PhD — Fondazione Policlinico Agostino Gemelli IRCCS
- Study coordinator: Gianluca Ianiro, MD, PhD
- Email: gianluca.ianiro@unicatt.it
- Phone: 0630159539
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.