Can poop pills beat superbugs? new trial aims to stop antibiotic resistance
NCT ID NCT07094984
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
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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
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
RECRUITINGWarsaw, Poland
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