FMT-UTI: Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06050148
• Collaborator: University of Helsinki (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 77
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Urinary Tract Infection	Biological: Feacal microbial transplantation (FMT); Other: Placebo transplantation (PT)	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Part A: Double-blinded randomised trial for volunteers with recurrent UTIs with 1:1 FMT and placebo (PT) arms undergoing transfer of feces or placebo, respectively (Groups 1 and 2). Randomisation with respect to ESBL positivity (equal numbers of ESBL-positive in FMT and PT arms) and menopause. The groups will undergo an intensive 12-month follow-up. (Part B: a concomitant separate non-randomised follow-up study for non-trial participants, recruited separately, groups 3 and 4, no further description)Part A: Double-blinded randomised trial for volunteers with recurrent UTIs with 1:1 FMT and placebo (PT) arms undergoing transfer of feces or placebo, respectively (Groups 1 and 2). Randomisation with respect to ESBL positivity (equal numbers of ESBL-positive in FMT and PT arms) and menopause. The groups will undergo an intensive 12-month follow-up. (Part B: a concomitant separate non-randomised follow-up study for non-trial participants, recruited separately, groups 3 and 4, no further description)
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.
• Primary Purpose: Prevention
• Official Title: Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
• Actual Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2028
• Anticipated Study Completion Date: Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Feacal microbial transplantation (FMT)	Biological: Feacal microbial transplantation (FMT); Feacal microbial transplantation (FMT)
Placebo Comparator: Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution	Other: Placebo transplantation (PT); Transplantation with coloured 0,9% NaCl-solution

Outcome Measures

Primary Outcome Measures

1. mean number of UTI episodes after FMT among patients with recurrent UTI [12 months]

2. proportion of participants with UTI after FMT among patients with recurrent UTI [12 months]

Secondary Outcome Measures

1. mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs [12 months]

2. proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs [12 months]

3. mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs [12 months]

4. proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs [12 months]

5. identifying groups of bacteria associated with smaller number of UTI episodes after FMT [12 months]

6. the duration of successful prevention by FMT [1-5 years]

7. proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain [12 months]

8. proportion of participants with intestinal ESBL/MDR eradicated after FMT [1-12 months]

9. confirm whether the uropathogen are identical before and after FMT [12 months]

   evaluated by antimicrobial sensitivity profile and whole-genome sequencing

10. number of antibiotic courses received by FMT versus placebo recipients [12 months]

11. proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT [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 [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 [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 [12 months]

15. human urine and serum metabolic profiles before and after FMT [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meilahti Vaccine Research Center, Helsinki University Central Hospital	Helsinki		Finland	00290

Sponsors and Collaborators

• Helsinki University Central Hospital
• University of Helsinki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HUS informational website for recruitment

Publications

None provided.

• Responsible Party: Anu Kantele, Professor of infectious diseases, University of Helsinki and Helsinki University Hospital, Department of infectious diseases, Meilahti Vaccine Research Center MeVac, Helsinki, Finland, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT06050148
• Other Study ID Numbers: FMT-UTI
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anu Kantele, Professor of infectious diseases, University of Helsinki and Helsinki University Hospital, Department of infectious diseases, Meilahti Vaccine Research Center MeVac, Helsinki, Finland, Helsinki University Central Hospital: Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance; Recurrent urinary tract infection; UTI
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence

Study Results

No Results Posted as of Sep 22, 2023