Recurrent urinary tract infections (rUTI)
Conditions
Brief summary
Rate of new UTI episodes within 180 days after treatment. A UTI for the endpoint assessment is defined as presence of at least one typical symptom (dysuria, alguria, pollakiuria or flank pain) in the absence of alternative causes plus the detection of a typical or potential uropathogen as defined by protocol by urinary culture.
Detailed description
Time to Post-FMT UTI: time to first UTI episode after treatment, Symptom burden: mean changes in ACSS score values on Day 7, 30, 90 and 180 compared to Baseline., Quality of Life: mean changes in score values on Day 30, 90 and 180 compared to Baseline, Number of new UTI episodes within 180 days after treatment caused by the same uropathogen as the last episode prior treatment, Antibiotic treatment frequency: Number of rUTI episodes treated with antibiotic until day 180, Vaginal infections: Number of episodes of bacterial vaginosis and/or candidosis until day 180, Assessment of safety: comparison of safety data between patients with or without FMT via review of nature, frequency and severity of adverse events (AEs), serious AEs (SAEs), and new medical conditions during six- month follow-up period
Interventions
DRUGMOVIPREP
DRUGPulver zur Herstellung einer Lösung zum Einnehmen
DRUGVANCOMYCIN
DRUGMonuril 3000 mg Granulat
DRUGPlacebo to INTESTIFIX 001
DRUGPlacebo to Vancomycin
DRUGINTESTIFIX 001
Sponsors
Goethe University Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of new UTI episodes within 180 days after treatment. A UTI for the endpoint assessment is defined as presence of at least one typical symptom (dysuria, alguria, pollakiuria or flank pain) in the absence of alternative causes plus the detection of a typical or potential uropathogen as defined by protocol by urinary culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Post-FMT UTI: time to first UTI episode after treatment, Symptom burden: mean changes in ACSS score values on Day 7, 30, 90 and 180 compared to Baseline., Quality of Life: mean changes in score values on Day 30, 90 and 180 compared to Baseline, Number of new UTI episodes within 180 days after treatment caused by the same uropathogen as the last episode prior treatment, Antibiotic treatment frequency: Number of rUTI episodes treated with antibiotic until day 180, Vaginal infections: Number of episodes of bacterial vaginosis and/or candidosis until day 180, Assessment of safety: comparison of safety data between patients with or without FMT via review of nature, frequency and severity of adverse events (AEs), serious AEs (SAEs), and new medical conditions during six- month follow-up period | — |
Countries
Germany
Outcome results
None listed