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Gut bacteria transplant tested against Antibiotic-Resistant urinary infections

NCT ID NCT07816913

Disease control Sponsor: The Second Hospital of Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether transplanting a purified mix of gut bacteria from healthy donors can clear urinary tract infections caused by multidrug-resistant organisms. About 10 adults with recurrent resistant UTIs will receive the transplant three times through a tube placed in the colon. The study tracks whether urine cultures turn negative, how often infections return, and changes in gut bacteria and immune markers over up to a year.

What this could mean

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

Active substance
washed microbiota transplantation, a purified mix of gut bacteria from screened healthy donors
What this could lead to
If it works, this could offer a way to treat stubborn urinary tract infections that no longer respond to antibiotics, possibly by fixing the gut bacteria that feed these infections.
What could go wrong
The trial is tiny, with about 10 people and no comparison group, so any benefit could be chance or not apply to others. Transplanting donor bacteria carries risks of infection, gut upset, and unknown long-term effects.

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

10 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2024

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: 1. Age ≥18 years, both sexes. 2. Recurrent UTI (symptomatic UTI or asymptomatic bacteriuria), with ≥2 episodes in the past 6 months or ≥3 episodes in the past year. 3. Clean-catch midstream urine culture at enrollment showing bacterial colony count ≥10\^5 CFU/ml, with multidrug-resistant organism (non-susceptible to ≥3 antimicrobial categories, including resistant and intermediate). 4. Physically eligible and willing to receive colonic TET tube placement and WMT treatment. 5. Able to provide informed consent and comply with scheduled follow-up visits and specimen collection. Exclusion Criteria: 1. Received effective antimicrobial therapy within 48 hours before WMT. 2. Unable to tolerate colonoscopy or TET tube placement. 3. Severe comorbidities with expected survival less than 6 months. 4. Pregnant or lactating women. 5. Other conditions deemed unsuitable for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

bacteriuria urinary tract infection urinary tract infections, recurrent, susceptibility to

As listed by the trial registrant

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

Bacteriuria Multidrug-resistant bacterial infections Recurrent urinary tract infections Urinary tract infections

Contacts and locations

Locations

  • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011, China

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