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Completed

NCT Number: NCT04550546

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 cause tooth decay.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eastman Dental Institute

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nystatin

Drug

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

Primary outcomes

  1. Mean change in S. Mutans carriage

    Time frame: baseline to 3 months

    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.

Secondary outcomes

  1. Mean C Albicans carriage

    Time frame: baseline to 3 months

    Subjects' whole non-stimulated saliva samples will be collected by spitting into a sterilized 50ml centrifuge tube. BBLTM CHROMagarTM Candida (BD, Sparks, MD, USA) will be used to isolate C. albicans (37°C for 48h). This medium permits presumptive identification of several clinically important Candida species including C. albicans based on colony color and morphology. C. albicans detection and carriage following nystatin suspension oral application using colony forming unit and scoring (1: no detection, 2: 1-400 CFU/mL; 3: >400 CFU/mL).

  2. Mean change in plaque index

    Time frame: baseline to 3 months

    Dental plaque status will be assessed using the Plaque Index. Each of the four gingival areas of the tooth will be given a score from 0-3. A score of 0 indicates no plaque in the gingival area, a score of 1 indicates the presence of a film of plaque adhering to the free gingival margin, a score of 2 indicates moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and or adjacent tooth, a score of 3 indicates abundance of soft matter within the gingival pocket and or on the gingival margin and adjacent tooth structure. The scores of each tooth surface will be added and divided by the number of teeth examined to obtain the plaque index score. Higher scores indicate worse outcome

  3. Mean change in number of bleeding on probing sites

    Time frame: baseline to 3 months

    Bleeding on probing (BOP) will be evaluated to reflect the periodontal status. With a periodontal probe, the periodontal tissue will be assessed to the bottom of the clinical pocket or sulcus. No extra effort will be made to apply a pressure. If bleeding occurs within 10-15 seconds after probing, the positive mark will be recorded on the form. Interproximal sites for every existing tooth, except the third molars, will be scored both from the buccal and the lingual sides. Due to the different numbers of existing teeth for each subject, the change in numbers of BOP sites will be measured and compared.

  4. Mean change in diversity as measured by the Shannon Index

    Time frame: baseline to 3 months

    We will use established methods to perform the oral microbiome sequencing and related bioinformatics analysis. Genomic DNA from clinical samples will be extracted. The bacterial 16S rRNA V1-V3 hypervariable region and fungal ITS region will be amplified and sequenced on an Illumina MiSeq. Absolute abundance of bacteria and fungi in each sample will be determined by quantitative real-time PCR using 16s and ITS primers, probe and cloned plasmid standards. Sequence reads will be assessed for quality using Quantitative Insights into Microbial Ecology software. USearch will be used to identify specific bacteria/fungi or operational taxonomic units using the GreenGenes and UNITE databases of reference sequences. Bacterial diversity within each sample (alpha diversity) will be computed as the Shannon Index. Equitability assumes a value between 0 and 1 with 1 being complete evenness.

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

    Time frame: baseline to 3 months

    We will use established methods to perform the oral microbiome sequencing and related bioinformatics analysis. Genomic DNA from clinical samples will be extracted. The bacterial 16S rRNA V1-V3 hypervariable region and fungal ITS region will be amplified and sequenced on an Illumina MiSeq. Absolute abundance of bacteria and fungi in each sample will be determined by quantitative real-time PCR using 16s and ITS primers, probe and cloned plasmid standards. Sequence reads will be assessed for quality using Quantitative Insights into Microbial Ecology software. USearch will be used to identify specific bacteria/fungi or operational taxonomic units using the GreenGenes and UNITE databases of reference sequences. Bacterial diversity between samples (beta diversity) will be computed as the Bray-Curtis dissimilarity index. The Bray-Curtis dissimilarity is a number between 0 (the two sites share all the same species) and 1 (they do not share any species).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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