The Oral Microbiome in OSCC

Oral Cancer Clinical Trial

Official title:

The Oral Microbiome in Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925700
• Other study ID #: 202012278
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or

2. 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:

1. Adults who have had a course of antibiotics that was completed less than 3 months prior to the study;

2. Adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics;

3. Adults who regularly use probiotic dietary supplements

4. Adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer

Intervention

Dietary Supplement:
• ProDentis Lozenge
1-2 ProDentis Lozenges per day

Other:
• Placebo Lozenge
1-2 Placebo Lozenges per day

Locations

Country	Name	City	State
United States	University of Iowa College of Dentistry and Dental Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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