Fecal microbiota transfer for the secondary prevention of recurrent urinary tract infections in premenopausal women: a phase II trial (FEMITRANS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Goethe University Frankfurt

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

12 May 2026 → ongoing

Decision date (initial)

2025-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Else Kröner-Fresenius Stiftung

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Assessment of the clinical efficacy of fecal microbiota transfer (FMT) in the prevention of rUTI episodes and investigation of donor and recipient microbiota factors that determine treatment success of FMT

Conditions and MedDRA coding

Recurrent urinary tract infections (rUTI)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. 2. Unsuccessful secondary prophylaxis of rUTI by lifestyle modifications including increased water intake and postcoital voiding
3. 3. Last acute symptomatic UTI episode confirmed by urinary culture and caused by either Escherichia coli or Klebsiella pneumoniae susceptible to fosfomycin
4. 4. Written informed consent obtained according to international guidelines and local laws
5. 5. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion criteria 15

1. 1. Inability to swallow 30 FMT capsules and undergo bowel lavage
2. 2. Known anatomical or functional abnormalities in the lower urinary tract including neurogenic bladder and incontinence
3. 3. Modifiable risk factors for rUTI (e.g. uncontrolled diabetes mellitus)
4. 4. Current pregnancy
5. 5. Uncontrolled 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.
6. 6. Presence of severe intestinal inflammation due to other cause
7. 7. Advanced stage chronic heart failure (NYHA III/IV)
8. 8. Gastrointestinal perforation, obstruction, ileus or retention of gastric contents
9. 9. Severe 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
10. 10. Known phenylketonuria or glucose-6-phosphate dehydrogenase deficiency
11. 11. Known allergy, hypersensitivity or intolerance to any of the used investigational medicinal products
12. 12. Planned or ongoing intake of prohibited concomitant medication as per protocol
13. 13. Currently enrolled in another interventional trial
14. 14. Failure 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).
15. 15. Other conditions that according to the investigator might interfere with the evaluation of study objectives or patient safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 7

1. Time to Post-FMT UTI: time to first UTI episode after treatment
2. Symptom burden: mean changes in ACSS score values on Day 7, 30, 90 and 180 compared to Baseline.
3. Quality of Life: mean changes in score values on Day 30, 90 and 180 compared to Baseline
4. Number of new UTI episodes within 180 days after treatment caused by the same uropathogen as the last episode prior treatment
5. Antibiotic treatment frequency: Number of rUTI episodes treated with antibiotic until day 180
6. Vaginal infections: Number of episodes of bacterial vaginosis and/or candidosis until day 180
7. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Goethe University Frankfurt

Sponsor organisation

Goethe University Frankfurt

Address

Theodor-Stern-Kai 7

City

Frankfurt Am Main

Postcode

60590

Country

Germany

Scientific contact point

Organisation

Goethe University Frankfurt

Contact name

Maria Vehreschild

Public contact point

Organisation

Goethe University Frankfurt

Contact name

Maria Vehreschild

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications