The Oral Microbiome in OSCC

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Tongue neoplasm
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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

July 1, 2021

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

, 3193359911, [email protected]

Administrative Informations

NCT ID

NCT04925700

Organization ID

202012278

Responsible Party

Principal Investigator

Study Sponsor

University of Iowa

Study Sponsor

, ,

Verification Date

June 2021