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NCT04550546 · ClinicalTrials.gov registry record · Phase 1
Effects of Nystatin Suspension Oral Application on Oral Microbial Community
A Phase 1 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04550546: Completed Phase 1 study, sponsored by University of Rochester.
NCT04550546 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04550546, a Phase 1 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cause tooth decay.
Primary Outcome
Subjects' whole non-stimulated saliva samples will be collected by spitting into a sterilized 50ml centrifuge tube. S. mutans will be isolated using Mitis Salivarius with Bacitracin selective medium (37°C for 48h) and identified by colony morphology. S. mutans carriage following nystatin suspension oral application using the colony forming unit and scoring (1: no detection, 2: 1-10,000 CFU/mL; 3: \>10,000 CFU/mL). Higher scores indicate worse outcome.
Interventions
- DRUG Nystatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
What the finished NCT04550546 record still lists
NCT04550546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Nystatin is the first listed.
NCT04550546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04550546 about?
NCT04550546 is a clinical study titled "Effects of Nystatin Suspension Oral Application on Oral Microbial Community". The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cau...
What is the current status of trial NCT04550546?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-05-15. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT04550546?
The interventions under investigation include: Nystatin (DRUG).
Who is sponsoring clinical trial NCT04550546?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04550546's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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