Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Lozenge | Experimental |
| |
| Placebo Lozenge | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProDentis Lozenge | Dietary Supplement | 1-2 ProDentis Lozenges per day |
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Drake, MS, PhD | University of Iowa College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry and Dental Clinics | Iowa City | Iowa | 52242 | United States |
Not provided
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Lozenge |
| Other |
1-2 Placebo Lozenges per day |
|
| D009057 |
| Stomatognathic Diseases |