The Oral Microbiome in OSCC

• ClinicalTrials.gov Identifier: NCT04925700
• Recruitment Status: Completed
• First Posted: June 14, 2021
• Last Update Posted: November 18, 2023
• Sponsor: University of Iowa
• Information provided by (Responsible Party): David R. Drake, University of Iowa

Tracking Information

• First Submitted Date: May 27, 2021
• First Posted Date: June 14, 2021
• Last Update Posted Date: November 18, 2023
• Actual Study Start Date: April 20, 2022
• Actual Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2021)

• Assessment of changes in the oral microbiome composition over time [ Time Frame: Up to 3 months ]
  16S Genomic Profiling will be done in all recruited subjects via oral swab of pre-cancerous or cancerous oral lesion
• Determine the Effect of ProDentis on the Oral Microbiome [ Time Frame: Up to 3 months ]
  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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Oral Cancer

Intervention

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

Study Arms

• Experimental: Probiotic Lozenge
  Intervention: Dietary Supplement: ProDentis Lozenge
• Placebo Comparator: Placebo Lozenge
  Intervention: Other: Placebo Lozenge

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2023): 20
• Original Estimated Enrollment (submitted: June 7, 2021): 24
• Actual Study Completion Date: October 10, 2023
• Actual Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04925700
• Other Study ID Numbers: 202012278
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: David R. Drake, University of Iowa
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Iowa
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Iowa
• Verification Date: November 2023