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

NCT07194941 | Completed Phase 2 DMC

• 1 other identifier: FEMINALE-II
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Urinary Tract Infections in Women

Keywords

Women; Urinary tract infections; Fecal microbiota

Outcome Measures

Primary Outcomes (1)

• Assess the usefulness of TMF in preventing episodes of ITUr.

  Proportion (%) of patients free of ITUr 12 months after the start of the study.

  12 months

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Tolerability and safety of FMT

  12 months

Study Arms (2)

Total dose of 150 g of fresh feces

EXPERIMENTAL

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

Biological: Freeze-dried product made of fresh feces

Total dose of 300 g of fresh feces

EXPERIMENTAL

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.

Biological: Freeze-dried product made of fresh feces

Interventions

Freeze-dried product made of fresh feces 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 150 g of fresh feces; Total dose of 300 g of fresh feces

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with lithiasis or permanent catheters (patients with self-catheters are excluded).

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

IRyCIS - FIBIO Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alex Soriano, MD

  HOSPITAL CLINIC DE BARCELONA, SPAIN

  PRINCIPAL INVESTIGATOR

• Antonio Ramos, MD

  HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, MADRID, SPAIN

  PRINCIPAL INVESTIGATOR

• Luis Llanes, MD

  HOSPITAL UNIVERSITARIO DE GETAFE, MADRID, SPAIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: August 25, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

ES (1)