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

NCT ID: NCT07194941

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2025-02-28

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

Conditions

Recurrent Urinary Tract Infections in Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total dose of 150 g of fresh feces

150 g freeze-dried product of fresh feces (\~30 capsules) to be taken throughout the day.

Group Type: EXPERIMENTAL

Freeze-dried product made of fresh feces

Intervention Type: BIOLOGICAL

FMT represents an ecological alternative for restoring the damaged intestinal ecosystem in this infection, increasing ecological diversity and thus limiting the spread of the pathogen. Recurrence of C. difficile is its only approved indication.

The impact of FMT on the intestinal ecosystem is attributable to intraspecific bacterial competition: commensal microorganisms (sensitive and non-virulent) have more effective growth rates than pathogenic bacteria (resistant and virulent), so FMT produces an ecological replacement in favor of grafting the donor microbiota and eliminating antibiotic-resistant clones.

Total dose of 300 g 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.

Group Type: EXPERIMENTAL

Freeze-dried product made of fresh feces

Intervention Type: BIOLOGICAL

FMT represents an ecological alternative for restoring the damaged intestinal ecosystem in this infection, increasing ecological diversity and thus limiting the spread of the pathogen. Recurrence of C. difficile is its only approved indication.

The impact of FMT on the intestinal ecosystem is attributable to intraspecific bacterial competition: commensal microorganisms (sensitive and non-virulent) have more effective growth rates than pathogenic bacteria (resistant and virulent), so FMT produces an ecological replacement in favor of grafting the donor microbiota and eliminating antibiotic-resistant clones.

Interventions

Freeze-dried product made of fresh feces

FMT represents an ecological alternative for restoring the damaged intestinal ecosystem in this infection, increasing ecological diversity and thus limiting the spread of the pathogen. Recurrence of C. difficile is its only approved indication.

The impact of FMT on the intestinal ecosystem is attributable to intraspecific bacterial competition: commensal microorganisms (sensitive and non-virulent) have more effective growth rates than pathogenic bacteria (resistant and virulent), so FMT produces an ecological replacement in favor of grafting the donor microbiota and eliminating antibiotic-resistant clones.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Soriano, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL CLINIC DE BARCELONA, SPAIN

Antonio Ramos, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, MADRID, SPAIN

Luis Llanes, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO DE GETAFE, MADRID, SPAIN

Locations

IRyCIS - FIBIO Hospital Ramón y Cajal

Madrid, , Spain

Countries

Spain

Other Identifiers

FEMINALE-II

Identifier Type: -

Identifier Source: org_study_id