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Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

ConditionRecurrent Urinary Tract Infection
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Suspected non-compliance

Diagnosis of a gastrointestinal disease

Pregnancy

Immunosuppression

Trial design

Design model

Parallel

Treatments tested in this trial

  • Feacal microbial transplantation (FMT)

    Biological/Vaccine

    Feacal microbial transplantation (FMT)

  • Placebo transplantation (PT)

    Other intervention

    Transplantation with coloured 0,9% NaCl-solution

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Feacal microbial transplantation (FMT)Experimental treatment 1 intervention
Group B: Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solutionPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

University of Helsinki

Collaborator

Source ClinicalTrials.gov
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