The Oral Microbiome in OSCC

Study Overview
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Brief Summary
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Previous work by a number of scientific teams has revealed that the types of bacteria that colonize the mouth differ between health and pre-cancerous or cancerous oral lesions. The purpose of this study is to investigate the extent of these changes and to correlate the changes with alterations in the activities of the host's own oral tissues. In doing so, we believe we can gain a better understanding of how particular bacterial species, or consortia of species, can result in an individual having an increased risk of the most common type of oral cancer -- oral squamous cell carcinoma. This knowledge may also lead to the identification of salivary biomarkers that can be used for clinical evaluation or screening. In addition, we seek to determine the extent to which a probiotic regimen can help prevent or rectify the disease-related changes in the types of bacterial colonizing the mouth. The microbiome in health, pre-cancerous lesions, and cancerous lesions will be determined from remnant microbial DNA in banked tissue samples. The effects of probiotics on the oral microbiome will be determined from DNA collected from swabs of oral tissue at baseline and then after 3 to 6 months of probiotic usage.

Official Title
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The Oral Microbiome in Oral Squamous Cell Carcinoma

Conditions
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Oral Cancer

Intervention / Treatment
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* Dietary Supplement: ProDentis Lozenge
* Other: Placebo Lozenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or Adults (21-70 years old) or who have been diagnosed with oral squamous cell carcinoma, or matched healthy controls free of any oral lesions Exclusion Criteria: Adults who have had a course of antibiotics that was completed less than 3 months prior to the study; Adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics; Adults who regularly use probiotic dietary supplements Adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Lozenge<br> | Dietary Supplement: ProDentis Lozenge<br>* 1-2 ProDentis Lozenges per day<br>|
| Placebo Comparator: Placebo Lozenge<br> | Other: Placebo Lozenge<br>* 1-2 Placebo Lozenges per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in the oral microbiome composition over time | 16S Genomic Profiling will be done in all recruited subjects via oral swab of pre-cancerous or cancerous oral lesion | Up to 3 months | 
| Determine the Effect of ProDentis on the Oral Microbiome | Pre-Cancerous lesion is treatment planned as watch-and-wait or oral lesion is not present, recruited subjects will be randomly assigned to either the probiotic lozenge or placebo lozenge group. | Up to 3 months |