Status:
COMPLETED
Efficacy and Safety of Fecal Microbiota Transfer (FMT) for Recurrent Urinary Tract Infections in Women
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Recurrent Urinary Tract Infections in Women
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07194941
Start Date
August 25 2022
End Date
February 28 2025
Last Update
September 26 2025
Active Locations (1)
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1
IRyCIS - FIBIO Hospital Ramón y Cajal
Madrid, Spain, 28034