Brief Title
The Oral Microbiome in OSCC
Official Title
The Oral Microbiome in Oral Squamous Cell Carcinoma
Brief 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.
Study Type
Interventional
Primary Outcome
Assessment of changes in the oral microbiome composition over time
Condition
Oral Cancer
Intervention
ProDentis Lozenge
Study Arms / Comparison Groups
Probiotic Lozenge
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
24
Start Date
April 20, 2022
Completion Date
August 2022
Primary Completion Date
July 2022
Eligibility Criteria
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.
Gender
All
Ages
21 Years - 89 Years
Accepts Healthy Volunteers
No
Contacts
David Drake, MS, PhD, (319) 335-7384, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04925700
Organization ID
202012278
Responsible Party
Principal Investigator
Study Sponsor
University of Iowa
Study Sponsor
David Drake, MS, PhD, Principal Investigator, University of Iowa College of Dentistry
Verification Date
May 2022