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Poop pills vs. superbugs: can a fecal transplant beat resistant gut bacteria?

NCT ID NCT04759001

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a fecal transplant from a healthy donor can clear carbapenem-resistant Enterobacteriaceae (CRE) from the gut of carriers. Fifty-two adults with CRE in their gut will be randomly assigned to receive either a real fecal transplant or a placebo via colonoscopy. Researchers will check rectal swabs over three months to see if the bacteria are gone.

What this could mean

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

Active substance
Fecal microbiota transplant (FMT) from healthy donors
What this could lead to
If it works, this could offer a way to clear dangerous drug-resistant bacteria from the gut, lowering the risk of serious infections.
What could go wrong
This is an early-phase trial with only 52 participants. Previous studies have shown mixed results, and the treatment may not work for everyone.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 52 people

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

Started

Feb 2021

Expected to finish

Aug 2026

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.

Ages

18 to 90 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 * 18 years old or older * Current evidence of gut colonisation (diagnosed with rectal swab) by CRE * Ability to give their consent to be included in the study. Exclusion criteria * Another known gastrointestinal infection apart from C. difficile infection * Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) * Previous colorectal surgery or cutaneous stoma * Food allergies * Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy * Unable to give informed consent

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Conditions

The condition(s) this trial relates to.

Enterobacteriaceae Infections

As listed by the trial registrant

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

Enterobacteriaceae infections Multi-antibiotic resistance

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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