NCT04550546

Effects of Nystatin Suspension Oral Application on Oral Microbial Community

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm clinical trial of patients diagnosed with oral candidiasis. designed clinical study. All study participants will have positive oral Candida detection with sufficient oral Candida burden to meet the laboratory criteria for a diagnosis of oral candidiasis (≥ 400 CFU/mL of salivary Candida, a standard that was established by Dr. Epstein at the Department of Oral Diagnosis and Department of Microbiology and Immunology at the University of Washington in 1980). All study participants will receive treatment for oral candidiasis using nystatin suspension (Brand name: Mycostatin), and be instructed to rinse the mouth with (6ml of 600,000 U/mL) nystatin suspension, followed by spitting out the suspension, at the frequency of four times per day, for a period of 1 week. The oral microbial changes including fungal and cariogenic bacteria (e.g. S. mutans) will be monitored immediately (within 7 days) and 3-months following the completion of the 1-week Nystatin application. Detailed inclusion and exclusion criteria and methods see below.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Nystatin	600,000 U/mL of nystatin in a rinse suspension

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2020-09-16
• Last updated: 2022-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study