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The Oral Microbiome in OSCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04925700
Recruitment Status : Completed
First Posted : June 14, 2021
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
David R. Drake, University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oral Cancer Dietary Supplement: ProDentis Lozenge Other: Placebo Lozenge Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Oral Microbiome in Oral Squamous Cell Carcinoma
Actual Study Start Date : April 20, 2022
Actual Primary Completion Date : October 10, 2023
Actual Study Completion Date : October 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925700


Locations
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United States, Iowa
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: David Drake, MS, PhD University of Iowa College of Dentistry
More Information
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Responsible Party: David R. Drake, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04925700    
Other Study ID Numbers: 202012278
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases