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NCT03050515 · ClinicalTrials.gov registry record · Early Phase 1
Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
A Early Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03050515: Completed Early Phase 1 study, sponsored by University of California, Irvine.
NCT03050515 is a Early Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03050515, a Early Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. With each documented infection, a patient receives anywhere from a three to seven day course of antibiotics for treatment. Repeated courses of antibiotics often lead to the development of multi-drug resistant infections that are difficult to treat with our arsenal of oral medications. It is theorized that most, if not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will likely be difficult to ever adequately treat repeat urinary tract infections. This same theory led to the development and utilization of fecal microbiota transplantation in the treatment of refractory Clostridium difficile diarrhea. There are now several studies that have reported on the efficacy of fecal transplantation in the treatment of C.difficile infections as well as the correction of gut dysbiosis. Given this positive response in treatment of refractory infectious diarrhea, the investigators propose that the correction of gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the investigators propose this pilot study to determine the effectiveness of fecal transplantation in the treatment of refractory, recurrent urinary tract infections.
Primary Outcome
Recurrent urinary tract infections are defined as 2 or more urine culture proven urinary tract infections in 6 months or 3 or more culture proven urinary tract infections in 12 months. To assess complete treatment success following fecal transplant, the investigators will collect urine cultures 1 month, 3 months and 6 months after fecal transplantation, as well as with any symptoms of a urinary tract infection, to determine the frequency of culture proven urinary tract infections over a 6 month
Interventions
- BIOLOGICAL Fecal Microbiota Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2020-02-23 |
| Phase | Early Phase 1 |
What the finished NCT03050515 record still lists
NCT03050515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT03050515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03050515 about?
NCT03050515 is a clinical study titled "Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections". Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3...
What is the current status of trial NCT03050515?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2018-02-05. Estimated completion is 2020-02-23.
What interventions are being tested in trial NCT03050515?
The interventions under investigation include: Fecal Microbiota Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03050515?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03050515's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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