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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04925700
Recruitment Status : Not yet recruiting
First Posted : June 14, 2021
Last Update Posted : December 10, 2021
Information provided by (Responsible Party):
David R. Drake, University of Iowa

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Oral Microbiome in Oral Squamous Cell Carcinoma
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : August 2022

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

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 identifier (NCT number): NCT04925700

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Contact: Jeff Banas 3193359911

Sponsors and Collaborators
University of Iowa
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Responsible Party: David R. Drake, Professor, University of Iowa Identifier: NCT04925700    
Other Study ID Numbers: 202012278
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021

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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
Mouth Diseases
Stomatognathic Diseases