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ProDentis Lozenge for Oral Neoplasms
N/A
Waitlist Available
Led By David Drake, MS, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Summary
This trial investigates whether taking probiotics can change the types of bacteria in the mouths of people with pre-cancerous or cancerous oral lesions. The goal is to see if these changes can lower their risk of developing oral cancer. Researchers will compare mouth swabs before and after a few months of probiotic use. Probiotics have shown potential in inhibiting oral carcinogenesis, with specific strains like L. salivarius REN significantly reducing the risk of developing oral cancer.
Eligible Conditions
- Oral Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of changes in the oral microbiome composition over time
Determine the Effect of ProDentis on the Oral Microbiome
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic LozengeExperimental Treatment1 Intervention
Group II: Placebo LozengePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ProDentis Lozenge
2022
N/A
~20
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
462 Previous Clinical Trials
891,973 Total Patients Enrolled
David Drake, MS, PhDPrincipal InvestigatorUniversity of Iowa College of Dentistry
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You take probiotic supplements regularly as part of your diet.You are an adult between the ages of 21 and 70 and have been diagnosed with oral squamous cell carcinoma, or you are a healthy person without any oral lesions who matches the criteria.You have taken antibiotics within the last 3 months before the study.You are taking medication or have a medical condition that weakens your immune system, which could make taking probiotics risky.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Lozenge
- Group 2: Probiotic Lozenge
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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