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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 is a Early Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03050515
The ClinicalTrials.gov registry entry for NCT03050515 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT03050515 reports 0 study locations.
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.
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