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Gut bacteria test could revolutionize colon cancer screening

NCT ID NCT06588166

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study aims to develop a new, non-invasive diagnostic tool for colorectal cancer by analyzing gut microbiome signatures in stool samples. Researchers will enroll 1006 participants aged 50-74 who have tested positive on the standard fecal immunochemical test (FIT). By combining clinical data with microbial analysis using machine learning, they hope to create a scoring system that more accurately identifies cancer and advanced adenomas, potentially reducing the number of unnecessary colonoscopies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gut microbiome testing
What this could lead to
If successful, this could provide a more accurate, non-invasive screening test for colorectal cancer, potentially reducing unnecessary colonoscopies.
What could go wrong
This is an observational study, not a treatment trial. The tool is still being developed and validated, so it may not prove accurate enough for widespread use.

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.

Participants

About 1,006 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Feb 2027

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.

Who is studied

Participants will be selected among those enrolled in the national colorectal cancer (CRC) screening program and among who refer to all centers involved in this study for screening colonoscopy. Patients meeting all inclusion criteria and none of the exclusion criteria will be considered eligible for this study. A total of n = 612 subjects will be enrolled. More specifically, 502 patients will be enrolled based on the updated sample size calculation. An additional 10 patients will be enrolled to account for a potential 2% dropout rate, as observed during the study conduct. Moreover, an independent validation cohort of 100 patients (approximately 20% of the main study cohort) will be enrolled to allow rigorous internal validation of the identified biomarkers and diagnostic models. Patients enrolled in the validation cohort will meet the same inclusion and exclusion criteria as the main study population and will undergo the same study procedures.

Ages

50 to 74 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal adenoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fondazione Policlinico Agostino Gemelli, IRCCS

    RECRUITING

    Roma, 00168, Italy

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