Can poop pills beat superbugs? new trial aims to stop antibiotic resistance

NCT ID NCT07094984

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tests three ways to remove antibiotic-resistant bacteria from the gut: fecal microbiota transplantation (FMT), a high-dose probiotic, or a special diet. 360 adults with confirmed gut colonization will be randomly assigned to one of these groups. The goal is to see if these approaches can clear the superbugs better than standard care, addressing the global threat of antibiotic resistance.

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 transplantation (FMT), probiotic therapy, or a gut-healthy diet
What this could lead to
If it works, this could provide a new way to clear dangerous superbugs from the gut without antibiotics, helping to slow the spread of antibiotic resistance.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The interventions may not work better than standard care, and FMT carries risks like infection or allergic reaction.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

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

Started

Dec 2024

Expected to finish

Apr 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: * Age ≥ 18 years; * Documented intestinal colonization with antibiotic-resistant bacteria confirmed by at least two positive cultures (rectal swabs or, alternatively, stool cultures), with the last positive result obtained at least 28 days prior to the planned procedure; * Documented colonization by one or more of the following bacterial strains: 1. Carbapenem-resistant strains with confirmed resistance mechanisms, including MBL+ (NDM+, VIM+, or others), KPC+, OXA-48+, or phenotypic carbapenem resistance without identified genetic mechanism; 2. Multidrug-resistant Enterobacteriaceae resistant to beta-lactams and other antibiotics, especially ESBL-producing strains, including Escherichia, Enterobacter, Klebsiella spp., and/or P. aeruginosa, A. baumannii (commonly associated with the ESKAPE group); 3. Gram-positive bacteria such as Enterococcus faecalis, Enterococcus faecium, or other vancomycin-resistant enterococci (VRE), as well as Staphylococcus aureus strains resistant to methicillin (MRSA) and/or vancomycin; * Absolute neutrophil count (ANC) in peripheral blood \>500/μL within 3 days prior to FMT; In case of tandem or repeated FMTs and expected neutrophil decline, the ANC test should be repeated before each FMT if the interval exceeds 3 days. For patients without expected neutropenia (\<500/μL), the blood count remains valid for 28 days; * Estimated life expectancy of at least 12 months; * Ability to swallow large capsules (confirmed using a test capsule) or absence of contraindications to colonoscopy; * No history of anaphylactic shock due to food allergies and ability to tolerate probiotic supplementation; * Provision of written informed consent to participate in the study. Exclusion Criteria: * Lack of consent to participate in the study or inability to establish logical contact and obtain consent from an authorized representative; * Absolute neutrophil count (ANC) \< 500 cells/μL on the day of FMT (within 3 days prior) or predicted decline to this level within the next 2 days; * Diagnosed HIV infection with CD4 lymphocyte count \< 250 cells/μL; * Active infection requiring antibiotic therapy on the day of FMT or planned antibiotic use during the first 7 days following FMT; * Symptoms or radiological/endoscopic evidence of gastrointestinal mucosal damage within 7 days prior to FMT (e.g., ulceration, perforation, gastrointestinal bleeding) posing a risk of serious adverse events; * Contraindications for FMT administration via upper or lower gastrointestinal tract routes (e.g., gastrointestinal perforation, anal atresia, lack of intestinal continuity, or other); * Inability to undergo preparatory therapy (oral antibiotics: colistin, vancomycin, gentamicin and/or bowel cleansing agents) prior to FMT; * Inability to swallow large capsules (confirmed with test capsules) or contraindications for colonoscopy; * Severe food allergy with history of anaphylactic shock or inability to tolerate probiotics; * Pregnancy or breastfeeding; * Severe medical conditions contraindicating study protocol adherence as determined by the treating physician (e.g., severe heart failure precluding bowel cleansing due to risk of fluid overload or dehydration); * Participation in another clinical trial and administration of an investigational drug or device within 3 months prior to randomization; * Reluctance or inability to comply with protocol requirements, including any physical, mental, or social condition that may impair the participant's ability to adhere to the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antimicrobial drug resistance are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

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

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych

    RECRUITING

    Warsaw, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.