Efficacy and Safety of Fecal Microbiota Transfer (FMT) for Recurrent Urinary Tract Infections in Women

Not Applicable

Completed

• Conditions: Recurrent Urinary Tract Infections in Women
• Interventions: Biological: Freeze-dried product made of fresh feces

• Registration Number: NCT07194941
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

Urinary tract infections (UTIs) are highly prevalent worldwide, especially in women, with frequent recurrences and significant healthcare costs. The proposed Phase II clinical trial will define dosing and administration strategies for FMT in recurrent UTIs. If effective, this ecological approach could provide a novel therapeutic alternative to antibiotics for one of the most common infectious diseases worldwide

Detailed Description

Urinary tract infections (UTIs) are highly prevalent worldwide, especially in women, with frequent recurrences and significant healthcare costs. Current treatment relies mainly on antibiotics, which contribute to antimicrobial resistance and adverse effects. While preventive strategies such as antibiotic prophylaxis, personalized vaccines, D-mannose, or hyaluronic acid instillations have been explored, they show limited success, partly because the intestinal tract acts as the reservoir for uropathogens.

This project proposes fecal microbiota transplantation (FMT) from healthy donors to modify the intestinal microbiome of patients with recurrent UTIs, aiming to eradicate intestinal colonization by resistant pathogens and prevent urinary infections. FMT, already approved for recurrent Clostridioides difficile since 2015, has evolved from colonoscopy-based procedures to oral capsules. Observations in clinical practice suggest FMT may incidentally clear recurrent UTIs and multidrug-resistant bacteria, though no formal indication exists yet due to lack of evidence on optimal dose and regimen.

The proposed Phase II clinical trial will define dosing and administration strategies for FMT in recurrent UTIs. If effective, this ecological approach could provide a novel therapeutic alternative to antibiotics for one of the most common infectious diseases worldwide

Study Timeline

• Study Start: 2022-08-25
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total dose of 150 g of fresh feces	Freeze-dried product made of fresh feces	150 g freeze-dried product of fresh feces (\~30 capsules) to be taken throughout the day.
Total dose of 300 g of fresh feces	Freeze-dried product made of fresh feces	Freeze-dried product made from 150 g of fresh feces (\~30 capsules) to be taken throughout the day. Subsequently, for 15 days (2 capsules per day in a single dose) made from 150 g of fresh feces. Receiving a total dose of 300 g of fresh feces.

Primary Outcome Measures

Name	Time	Method
Assess the usefulness of TMF in preventing episodes of ITUr.	12 months	Proportion (%) of patients free of ITUr 12 months after the start of the study.

Secondary Outcome Measures

Name	Time	Method
Tolerability and safety of FMT	12 months	Proportion of the following adverse reactions: diarrhoea, abdominal pain, nausea, fever, low-grade fever, abdominal distension, vomiting, constipation, flatulence, rectal bleeding, skin rash, others).
To evaluate the efficacy of two different TMF dosages in modifying the microbiota and achieving a reduction in the frequency of episodes in patients with rUTI.	12 months	Annual recurrence rate (number of recurrences per patient per year, additional clinical information such as whether the symptoms are more like cystitis or pyelonephritis, and the need for hospital admission).
FMT impact on intestinal bacterial ecosystem	12 months	Document clonal replacement in classical cultivable bacteria and demonstrate the impact of FMT on the entire intestinal bacterial ecosystem through next-generation sequencing of the 16S rDNA gene and metabolic monitoring by determining short-chain fatty acids.

Trial Locations

Locations (1)

IRyCIS - FIBIO Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain