Effects of Nystatin Suspension Oral Application on Oral Microbial Community

NCT ID: NCT04550546

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nystatin treatment

Participants will be given 1-week supply of nystatin suspension (6ml 600,000 U/mL) and be instructed to rinse the mouth with nystatin for 1 minute and spit out the suspension, at a frequency of four times a day, for a duration of 1 week. Participants will be instructed to spit the suspension after the oral rinse and do not swallow the suspension, and they will be instructed to avoid eating, drinking and brushing their teeth for 30 minutes.

Group Type: EXPERIMENTAL

Nystatin

Intervention Type: DRUG

600,000 U/mL of nystatin in a rinse suspension

Interventions

Nystatin

600,000 U/mL of nystatin in a rinse suspension

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing to participate in this study and able to come for follow-up appointments.
• Has positive oral Candida detection and the amount of oral Candida meet the laboratory criteria for diagnosing oral Candidiasis (>= 400 colony forming unit in saliva).
• Has ≥ 10,000 CFU/mL of S. mutans in the saliva (justification: individuals with ≥ 10,000 CFU/mL salivary S. mutans are considered at elevated risk for dental caries).
• Ability to consent, comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

• visible signs of candidiasis on the mucosa or tongue at screening (Patients will be referred for treatment immediately)
• Patient with systemic diseases, such as HIV, cancer or diabetes. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system. (Justification: patient with systemic diseases is that patients with these conditions are more prone to yeast and bacterial infection)
• History of local (oral) or systemic antibiotics or antifungal medication within the last 3 months. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system.
• Women who are currently pregnant or reported that she is currently breast feeding . A pregnancy test (urine test) will be conducted to exclude participants who are pregnant. Rational of excluding pregnant women and women are currently breastfeeding their children: Nystatin oral suspension is classified as FDA pregnancy risk category C. It's also unknown whether nystatin is excreted in human milk.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Jin Xiao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Xiao, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Eastman Dental Institute

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00004638

Identifier Type: -

Identifier Source: org_study_id