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NCT Number: NCT06050148

Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

This study investigates Faecal microbiota transplantation (FMT) in prevention of recurrent urinary tract infections (UTIs) caused either by sensitive E. coli or ESBL-E. coli.

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Key information

Conditions

Recurrent Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Meilahti Vaccine Research Center, Helsinki University Central Hospital

Helsinki, 00290, Finland

Location status: Recruiting

Location contact

Hanni Häkkinen, MD

SUB_INVESTIGATOR

Meilahti Vaccine Research Center

CONTACT

[email protected]

Sari Pakkanen, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female subjects aged ≥18
  • History of recurrent UTI: at least two episodes of UTI over the past 6 months or at least three episodes over the past year, most recent episode within the past three months
  • Written informed consent

Exclusion criteria

  • Suspected non-compliance
  • Diagnosis of a gastrointestinal disease
  • Pregnancy
  • Immunosuppression
  • Any kind of permanent urinary catheter or intermittent urinary catheterization
  • Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Treatment and study plan

Feacal microbial transplantation (FMT)

Biological

Feacal microbial transplantation (FMT)

Placebo transplantation (PT)

Other

Transplantation with coloured 0,9% NaCl-solution

Primary outcomes

  1. mean number of UTI episodes after FMT among patients with recurrent UTI

    Time frame: 12 months

  2. proportion of participants with UTI after FMT among patients with recurrent UTI

    Time frame: 12 months

Secondary outcomes

  1. mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs

    Time frame: 12 months

  2. proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs

    Time frame: 12 months

  3. mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs

    Time frame: 12 months

  4. proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs

    Time frame: 12 months

  5. identifying groups of bacteria associated with smaller number of UTI episodes after FMT

    Time frame: 12 months

  6. the duration of successful prevention by FMT

    Time frame: 1-5 years

  7. proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain

    Time frame: 12 months

  8. proportion of participants with intestinal ESBL/MDR eradicated after FMT

    Time frame: 1-12 months

  9. confirm whether the uropathogen are identical before and after FMT

    Time frame: 12 months

    evaluated by antimicrobial sensitivity profile and whole-genome sequencing

  10. number of antibiotic courses received by FMT versus placebo recipients

    Time frame: 12 months

  11. proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT

    Time frame: 1-12 months

    Gastrointestinal symptom rating scale -questionnaire with 15 items on a 7-level Likert scale (1-7), higher scores for more intense symptoms during the past week

  12. proportion of participants with mild to severe depression assessed by BDI scores before and after FMT

    Time frame: 1-12 months

    Beck's Depression Inventory: 21-question multiple-choice self-report inventory, higher scores for more severe depression

  13. mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT

    Time frame: 1-12 months

    Quality of life -questionnaire (15D): a generic, comprehensive (15-dimensional), self-administered questionnaire, lower scores for better HRQoL

  14. description of groups of bacteria in faecal and urine microbiome before and after FMT

    Time frame: 12 months

  15. human urine and serum metabolic profiles before and after FMT

    Time frame: 12 months

    assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach

Study contacts

Contact information is provided by the study sponsor or research team.

Sari Pakkanen, PhD

CONTACT

[email protected]

+358 50 4482769 ext. +358

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Acronym: FMT-UTI

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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