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Mapping the microbiome: could personalized gut bacteria testing transform intestinal care?

NCT ID NCT06845527

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study aims to characterize the gut microbiome and immune markers of 400 adults visiting a specialized gut microbiota clinic. By analyzing stool and saliva samples alongside blood cytokine profiles, researchers hope to build a database linking microbial patterns to intestinal health. The goal is to better understand how microbiome testing might guide future treatments.

What this could mean

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

What this could lead to
If successful, this research could help standardize how gut microbiome testing is used in clinical care, potentially guiding personalized treatments for intestinal disorders.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The findings may not apply to broader populations outside this single clinic.

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 400 people

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

Started

Mar 2025

Expected to finish

Mar 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

Outpatients attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Ages

18 years and older

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 * Age ≥18 years. * Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS. * Ability to understand the study procedures and provide written informed consent. * Patients for whom gut microbiota testing has been requested as part of routine clinical care. Exclusion Criteria * Age \<18 years. * Severe psychiatric disorders that may interfere with study participation or informed consent. * Inability to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

intestinal disorder

As listed by the trial registrant

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

Intestinal disease

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

  • Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, RM, 00168, Italy

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