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Poop pills aim to stamp out superbugs in the gut

NCT ID NCT07106580

Disease control Sponsor: University of Rijeka 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether capsules containing freeze-dried stool from healthy donors can safely remove multidrug-resistant organisms (MDROs) from the intestines of 48 adults who carry these bacteria without symptoms. Participants will take either the fecal transplant capsules or a placebo over 3 days and be monitored for 6 months. The goal is to see if this approach can decolonize the gut and prevent future infections.

What this could mean

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

Active substance
lyophilized fecal microbiota transplantation (FMT) capsules
What this could lead to
If it works, this could offer a simple, pill-based way to eliminate dangerous drug-resistant bacteria from the gut, reducing infection risk.
What could go wrong
This is an early Phase 1/2 trial with only 48 participants, so results may not apply broadly. The treatment may not clear the bacteria, and side effects are still being studied.

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 48 people

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

Started

Jul 2025

Expected to finish

Sep 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.

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: * ≥ 18 years, * stool sample or rectal swab positive for MDRO (CRE, ESBL-E, VRE) within a week of randomization, * capable of swallowing oral capsules, * willing to give informed consent Exclusion Criteria: * antibiotic treatment on the day of inclusion, * pregnant or breastfeeding, women of childbearing potential who are unwilling or unable to use an acceptable method of birth control, * patients with terminal diseases with expected life expectancy \< 6 months, * unwillingness to ingest the capsules, * a history of colectomy, present colostomy or ileostomy, * patients with the diagnosis/treatment of inflammatory or functional bowel disease, * patients with malignant bowel diseases, * absolute neutrophil count \< 500/mm3, * selective digestive decolonization with antibiotics within 6 months before randomization, * severe allergy to capsule components

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Conditions

The condition(s) this trial relates to.

Asymptomatic Infections

As listed by the trial registrant

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

Colonization, asymptomatic

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

  • Clinical Hospital Center Rijeka

    RECRUITING

    Rijeka, 51000, Croatia

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