INTESTIFIX for Recurrent urinary tract infection

Inclusion criteria

• {"criterion_text":"- 1. Premenopausal adult women with recent history of rUTI defined as ≥ four UTI during the last 12 months. A UTI is defined as presence of at least one typical symptom (dysuria, alguria, pollakiuria or flank pain) in the absence of alternative causes.\n- 2. Unsuccessful secondary prophylaxis of rUTI by lifestyle modifications including increased water intake and postcoital voiding\n- 3. Last acute symptomatic UTI episode confirmed by urinary culture and caused by either Escherichia coli or Klebsiella pneumoniae susceptible to fosfomycin\n- 4. Written informed consent obtained according to international guidelines and local laws\n- 5. Ability to understand the nature of the trial and the trial related procedures and to comply with them"}

Exclusion criteria

• {"criterion_text":"- 1.\tInability to swallow 30 FMT capsules and undergo bowel lavage\n- 10.\tKnown phenylketonuria or glucose-6-phosphate dehydrogenase deficiency\n- 11.\tKnown allergy, hypersensitivity or intolerance to any of the used investigational medicinal products\n- 12.\tPlanned or ongoing intake of prohibited concomitant medication as per protocol\n- 13.\tCurrently enrolled in another interventional trial\n- 14.\tFailure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception; e.g. Women can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study; (see section 7.5.3).\n- 15.\tOther conditions that according to the investigator might interfere with the evaluation of study objectives or patient safety.\n- 2.\tKnown anatomical or functional abnormalities in the lower urinary tract including neurogenic bladder and incontinence\n- 3.\tModifiable risk factors for rUTI (e.g. uncontrolled diabetes mellitus)\n- 4.\tCurrent pregnancy\n- 5.\tUncontrolled inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease) defined as the necessity to start or modify immunosuppressive treatment within the preceding three months due to disease activity.\n- 6.\tPresence of severe intestinal inflammation due to other cause\n- 7.\tAdvanced stage chronic heart failure (NYHA III/IV)\n- 8.\tGastrointestinal perforation, obstruction, ileus or retention of gastric contents\n- 9.\tSevere immunosuppression defined as at least one of the following: (a) patients with current or foreseeable neutropenia within the 14 days of study treatment (defined as <500 neutrophils/ml) (b) patients scheduled for or having received CAR-T-cell therapy or allogeneic stem cell transplantation (SCT) or solid organ transplantation within 100 days prior or after enrolment (c) patients with active graft versus host disease or allograft rejection requiring intensified immunosuppressive treatment (d) patients treated with corticosteroids equivalent to prednisone ≥20 mg daily for 14 consecutive days prior or after enrollment (e) patients with HIV infection with CD4+ cell count <200/mm³ within the past 3 months of screening"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessment over 180 days post-treatment; UTI defined as presence of ≥1 typical symptom plus detection of a typical or potential uropathogen by urinary culture."}

Secondary endpoints

• {"endpoint_text":"- Time to Post-FMT UTI: time to first UTI episode after treatment","definition_or_measurement_approach":"Time from treatment to first UTI episode."}
• {"endpoint_text":"- Symptom burden: mean changes in ACSS score values on Day 7, 30, 90 and 180 compared to Baseline.","definition_or_measurement_approach":"Change in ACSS scores at Days 7, 30, 90 and 180 versus baseline; mean change compared."}
• {"endpoint_text":"- Quality of Life: mean changes in score values on Day 30, 90 and 180 compared to Baseline","definition_or_measurement_approach":"Mean change in QoL score values at Days 30, 90 and 180 versus baseline."}
• {"endpoint_text":"- Number of new UTI episodes within 180 days after treatment caused by the same uropathogen as the last episode prior treatment","definition_or_measurement_approach":"Count of new UTI episodes within 180 days with same uropathogen as pre-treatment episode."}
• {"endpoint_text":"- Antibiotic treatment frequency: Number of rUTI episodes treated with antibiotic until day 180","definition_or_measurement_approach":"Count of rUTI episodes treated with antibiotics up to day 180."}
• {"endpoint_text":"- Vaginal infections: Number of episodes of bacterial vaginosis and/or candidosis until day 180","definition_or_measurement_approach":"Count of episodes of bacterial vaginosis and/or candidosis up to day 180."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Comparison of AEs, SAEs and new medical conditions over six-month follow-up between groups."}

Germany

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

253

Number Of Sites

3

Number Of Participants

24

Primary sponsor

Full Name

Goethe University Frankfurt

Organisation Type

Educational Institution

Country Of Registered Address

Germany