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Recruiting Phase 2, Phase 3 NCT06050148

NCT06050148 Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

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Clinical Trial Summary
NCT ID NCT06050148
Status Recruiting
Phase Phase 2, Phase 3
Sponsor Helsinki University Central Hospital
Condition Recurrent Urinary Tract Infection
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2023-08-01
Primary Completion 2028-12-31

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 90 Years
Study Type INTERVENTIONAL
Interventions
Feacal microbial transplantation (FMT)Placebo transplantation (PT)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 100 participants in total. It began in 2023-08-01 with a primary completion date of 2028-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Sari Pakkanen, PhD

✉ vti-tutkimus@hus.fi

📞 +358 50 4482769

Frequently Asked Questions

Who can join the NCT06050148 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 90 Years, studying Recurrent Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06050148 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT06050148 currently recruiting?

Yes, NCT06050148 is actively recruiting participants. Contact the research team at vti-tutkimus@hus.fi for enrollment information.

Where is the NCT06050148 trial being conducted?

This trial is being conducted at Helsinki, Finland.

Who is sponsoring the NCT06050148 clinical trial?

NCT06050148 is sponsored by Helsinki University Central Hospital. The trial plans to enroll 100 participants.

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