The Oral Microbiome in OSCC

The Oral Microbiome in Oral Squamous Cell Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer
• Intervention / Treatment: Dietary supplement: ProDentis Lozenge; Other: Placebo Lozenge

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Dentistry and Dental Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Lozenge	Dietary supplement: ProDentis Lozenge; 1-2 ProDentis Lozenges per day
Placebo Comparator: Placebo Lozenge	Other: Placebo Lozenge; 1-2 Placebo Lozenges per day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: David Drake, MS, PhD, University of Iowa College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms
• Other Study ID Numbers: 202012278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No