The Oral Microbiome in OSCC

NCT04925700 | Completed

• 1 other identifier: 202012278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Probiotic Lozenge

EXPERIMENTAL

Dietary Supplement: ProDentis Lozenge

Placebo Lozenge

PLACEBO COMPARATOR

Other: Placebo Lozenge

Interventions

ProDentis Lozenge DIETARY_SUPPLEMENT

1-2 ProDentis Lozenges per day

Probiotic Lozenge

Placebo Lozenge OTHER

1-2 Placebo Lozenges per day

Placebo Lozenge

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• David Drake, MS, PhD

  University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 14, 2021
• Study Start: April 20, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)