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Gut bacteria clues sought for Post-Infection IBS

NCT ID NCT07517029

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study is looking at the gut microbiome of 315 people, including those with irritable bowel syndrome that started after an infection. Researchers will compare their gut bacteria to people who had an infection but no IBS, and to healthy controls. The goal is to find specific bacterial patterns linked to the disease, which could lead to better understanding and 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 could identify specific gut bacteria linked to post-infection IBS, pointing toward future microbiome-based treatments.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear microbial signatures, and any findings will need years of further research to become therapies.

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 315 people

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

Started

Apr 2026

Expected to finish

Dec 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.

Who is studied

Participants will include adults with post-infectious irritable bowel syndrome (PI-IBS) (n= 105) and two control groups: individuals with a history of acute gastroenteritis without persistent gastrointestinal symptoms (n = 105) , and healthy subjects (n = 105) . All participants will be recruited from clinical centers and donor programs and will undergo clinical assessment and stool sample collection for microbiome analysis.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

PI-IBS patients (n = 105) * Inclusion criteria * Age ≥ 18 years old * PI-IBS diagnosed according to Rome IV criteria (33). * Diagnosis no earlier than 3 months before enrollment. * Written informed consent and compliance with study procedures. * Exclusion criteria * Chronic organic gastrointestinal (GI) disorders (e.g. Inflammatory Bowel Disease -IBD), metabolic syndrome, obesity, diabetes, GI cancers, systemic autoimmune disorders. * History of major abdominal surgery. Control cohort #1 - Post-infectious non-IBS (n = 105) * Inclusion criteria * Age ≥ 18 years old * History of acute infectious gastroenteritis \>6 months before enrollment. * Complete recovery without persistent GI symptoms. * Exclusion criteria * Current or past diagnosis of IBS. * Any chronic GI or systemic disorders. Control cohort #2 - Healthy subjects (n = 105) * Inclusion criteria * Age ≥ 18 years old * Healthy donors from FMT program or blood donor program. * No history of GI or systemic disorders. * Exclusion criteria * Any GI or systemic chronic condition. * Recent antibiotics/probiotics (\<4 weeks). * Chronic medication affecting microbiome composition (e.g. PPI)

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome Post-Infectious Disorders post-infectious syndrome

As listed by the trial registrant

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

IBS - irritable bowel syndrome Post infection syndrome

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

  • Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

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