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Study on Fecal Microbiota Transfer for Preventing Recurrent Urinary Tract Infections in Premenopausal Women Using Intestifix

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a treatment called fecal microbiota transfer (FMT) for preventing recurrent urinary tract infections (rUTI) in premenopausal women. Recurrent urinary tract infections are infections that happen frequently, causing symptoms like pain during urination, frequent urination, or pain in the lower back. The study aims to see if FMT can help reduce the number of these infections by introducing healthy bacteria from a donor's stool into the patient's gut, which may help restore a healthy balance of bacteria.

The trial will compare the effects of FMT with other treatments, including Monuril 3000 mg Granulat, which contains the active ingredient fosfomycin trometamol, and Vancomycin, an antibiotic. Additionally, a product called INTESTIFIX 001, derived from donor stool, will be used. Some participants will receive a placebo, which looks like the real treatment but does not contain the active ingredients. The study will monitor participants over a period to see how many new urinary tract infections occur and how quickly they happen after treatment.

Throughout the study, participants will be observed for any changes in their symptoms and overall quality of life. The trial will also assess the safety of FMT by reviewing any side effects or new medical conditions that arise during the follow-up period. The goal is to understand how effective FMT is in preventing recurrent urinary tract infections and to identify factors that contribute to its success.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
You must meet certain criteria, such as being a premenopausal adult woman with a history of recurrent urinary tract infections (rUTI).
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and any recent urinary tract infections.
A urinary culture may be performed to ensure the infection is caused by bacteria susceptible to the study medication.
Step 3
Treatment phase
During the treatment phase, you may receive a fecal microbiota transfer (FMT) to help prevent future urinary tract infections.
You will also be given medications such as Monuril 3000 mg Granulat and Vancomycin, both taken orally. The specific dosage and frequency will be explained by the study team.
Step 4
Follow-up visits
You will have follow-up visits on Day 7, 30, 90, and 180 after the treatment to monitor your health and any symptoms.
During these visits, your quality of life and any changes in symptoms will be assessed.
Step 5
Monitoring and reporting
Throughout the trial, you will be asked to report any new urinary tract infections or other health issues.
The study team will monitor your condition and any side effects from the treatment.
Step 6
End of trial
The trial will conclude after 180 days of follow-up. Your participation will help assess the effectiveness of the treatment in preventing recurrent urinary tract infections.
You will receive a final assessment to review your overall health and any outcomes from the trial.

Who can join the trial?

6 criteria

Must be a premenopausal adult woman. This means a woman who has not yet gone through menopause.
Must have a recent history of recurrent urinary tract infections (rUTI), defined as having four or more urinary tract infections in the last 12 months. A urinary tract infection is when you have at least one typical symptom like painful urination, frequent urination, or pain in the side, without other causes.
Must have tried and not succeeded with lifestyle changes to prevent rUTI, such as drinking more water and urinating after sex.
The last urinary tract infection must have been confirmed by a urine test and caused by bacteria called Escherichia coli or Klebsiella pneumoniae that can be treated with a specific antibiotic called fosfomycin.
Must be able to give written informed consent, which means you understand the study and agree to participate according to international and local laws.
Must be able to understand the nature of the trial and follow the trial procedures.

Who cannot join the trial?

3 criteria

Patients who are male cannot participate in the study.
Patients who are under the age of 18 cannot participate in the study.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Goethe University Frankfurt
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Frankfurt, Germany
Universitaetsklinikum Schleswig-Holstein AöR
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Kiel, Germany
University Hospital Cologne
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Cologne, Germany

Trial locations

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Investigated drugs

Fecal Microbiota Transfer (FMT) is a therapy that involves taking healthy bacteria from the stool of a donor and transferring it to the intestines of a patient. The goal of this treatment is to restore the natural balance of bacteria in the patient's gut. In this clinical trial, FMT is being tested to see if it can help prevent recurrent urinary tract infections in premenopausal women. By introducing healthy bacteria, the therapy aims to strengthen the body's natural defenses against infections.

Vancomycin

What is already known about the treatment

Fecal Microbiota Transfer (FMT) – Fecal Microbiota Transfer is administered through a procedure where processed stool from a healthy donor is introduced into the gastrointestinal tract of a recipient, often via colonoscopy, enema, or oral capsules. Currently, FMT is being explored in clinical trials for its potential to prevent recurrent urinary tract infections (rUTI) in premenopausal women, with ongoing research assessing its effectiveness and the role of microbiota in treatment success. The main therapeutic indication for FMT in this context is the prevention of rUTI episodes. At the molecular level, FMT works by restoring a healthy balance of gut bacteria, which can help in reducing the frequency of infections. It is classified under microbiota-based therapies, focusing on altering the gut flora to achieve therapeutic benefits.

Investigated diseases

Recurrent urinary tract infections (rUTI) – Recurrent urinary tract infections are characterized by multiple episodes of infection in the urinary tract, which includes the bladder, urethra, ureters, and kidneys. These infections are typically caused by bacteria, most commonly Escherichia coli, that enter the urinary tract. Symptoms often include a strong, persistent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. In some cases, individuals may experience pelvic pain or flank pain. The condition is more common in women than men, due to anatomical differences. Recurrent infections can lead to discomfort and may require ongoing management to prevent further episodes.