Effects of Nystatin Suspension Oral Application on Oral Microbial Community

NCT04550546 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY00004638
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Mean change in S. Mutans carriage

  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.

  baseline to 3 months

Secondary Outcomes (5)

• Mean C Albicans carriage

  baseline to 3 months

• Mean change in plaque index

  baseline to 3 months

• Mean change in number of bleeding on probing sites

  baseline to 3 months

• Mean change in diversity as measured by the Shannon Index

  baseline to 3 months

• Mean change in diversity as measured by the Bray-Curtis dissimilarity index

  baseline to 3 months

Study Arms (1)

Nystatin treatment

EXPERIMENTAL

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.

Drug: Nystatin

Interventions

Nystatin DRUG

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

Nystatin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Eastman Dental Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Jin Xiao, DDS, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: May 15, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

US (1)