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Your gut bacteria might reveal hidden cancer risk

NCT ID NCT06738173

Diagnosis Sponsor: Catholic University of the Sacred Heart 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study is looking at whether the mix of bacteria in the gut can serve as a warning sign for colorectal cancer and advanced polyps. Researchers will collect stool samples from people aged 50-74 who are part of a national screening program and have had a positive fecal immunochemical test (FIT). By analyzing the microbiome and comparing it with colonoscopy results, they aim to build a scoring tool that could one day make screening more accurate and less invasive.

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 lead to a non-invasive stool test that improves colorectal cancer screening, reducing unnecessary colonoscopies and catching more cancers early.
What could go wrong
The test is still in development and may not prove accurate enough to replace current methods. Also, the study is observational, so it can't prove cause and effect.

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 1,202 people

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

Started

Feb 2025

Expected to finish

Sep 2029

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 with all inclusion criteria and none of the exclusion criteria will be considered for this study. A total of 1202 patients will be enrolled, based on sample size calculation and including a validation group. N=911 patients will be needed, and we will add 91 patients to cover a 10% potential drop-out and 200 patients as a validation group (20% of the study cohort). Patients enrolled in this validation cohort will have the same exclusion and inclusion criteria of other patients 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

  • Catholic University of the Sacred Heart

    RECRUITING

    Rome, RM, 00168, Italy

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