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NCT03452189 · ClinicalTrials.gov registry record · Phase 2
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03452189: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT03452189 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452189, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.
Primary Outcome
Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Interventions
- OTHER Placebo
- DRUG Vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2018-08-18 |
| Phase | Phase 2 |
What the finished NCT03452189 record still lists
NCT03452189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03452189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03452189 about?
NCT03452189 is a clinical study titled "The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome". The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators t...
What is the current status of trial NCT03452189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2017-11-27. Estimated completion is 2018-08-18.
What interventions are being tested in trial NCT03452189?
The interventions under investigation include: Placebo (OTHER), Vancomycin (DRUG).
Who is sponsoring clinical trial NCT03452189?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03452189's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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