Clinical trial NCT04550546: Effects of Nystatin Suspension Oral Application on Oral Microbial Community
Official title: Effects of Nystatin Suspension Oral Application on Oral Microbial Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean change in S. Mutans carriage
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Mean C Albicans carriage
timeFrame: baseline to 3 months
measure: Mean change in plaque index
timeFrame: baseline to 3 months
measure: Mean change in number of bleeding on probing sites
timeFrame: baseline to 3 months
measure: Mean change in diversity as measured by the Shannon Index
timeFrame: baseline to 3 months
measure: Mean change in diversity as measured by the Bray-Curtis dissimilarity index
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Eastman Dental Institute
state: New York
Study officials:
affiliation: University of Rochester
name: Jin Xiao, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: