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Poop pills could stop recurrent UTIs without antibiotics

NCT ID NCT07194941

Disease control Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This completed Phase 2 trial tested fecal microbiota transfer (FMT) – a freeze-dried product made from healthy donor stool – in 40 women with recurrent urinary tract infections (UTIs). The goal was to see if FMT could prevent future UTIs by restoring healthy gut bacteria. Researchers compared two different doses and tracked how many women remained infection-free for 12 months. If effective, FMT could become a new antibiotic-free option for this common condition.

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) – a freeze-dried product made from healthy donor stool
What this could lead to
If it works, this could offer a new, non-antibiotic way to prevent frequent urinary tract infections in women, reducing the need for repeated antibiotics.
What could go wrong
This is a small Phase 2 trial with only 40 women, so results may not apply to everyone. FMT is still experimental for UTIs and 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Aug 2022

Finished

Feb 2025

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

Female participants only

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: Women ≥18 years of age with UTIs (≥3 episodes in one year or ≥2 in six months) who meet at least one of the following criteria * UTIs despite having used other prophylactic strategies. * HUTI due to resistant bacteria (ESBL- or carbapenemase-producing Enterobacteriaceae, and quinolone-resistant Pseudomonas aeruginosa or Enterococcus faecium). * Allergy or previous adverse reactions to available oral antibiotics (usually beta-lactams, but could occur with other antibiotic families) for prophylaxis and/or treatment. Exclusion Criteria: * Have symptoms compatible with symptomatic UTI at the time of inclusion or be undergoing treatment for it. * Be receiving another preventive strategy for UTIs at the time of study inclusion: prophylactic antibiotics, bladder instillation with hyaluronic acid, D-mannose, or therapeutic vaccines. In the case of the latter, Version 3.0\_ March 22, 2023 13 patients who have received them must have had at least two recurrences despite their administration. * Rifaximin allergy. * Inability to understand the study and sign the informed consent form, and to collect stool and urine samples. * Pregnancy or breastfeeding * Patients with bone marrow or solid organ transplants (patients who have been transplanted for ≥ 5 years and are stable from a transplant perspective are allowed to be included). * Any clinically significant disease at the investigator's discretion, other than UTIs, that is not medically controlled at the time of study inclusion. * Patients with lithiasis or permanent catheters (patients with self-catheters are excluded).

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Conditions

The condition(s) this trial relates to.

bacterial urinary tract infection 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.

Recurrent urinary tract infections in women

Contacts and locations

Locations

  • IRyCIS - FIBIO Hospital Ramón y Cajal

    Madrid, Madrid, 28034, Spain

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