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NCT04925700 · ClinicalTrials.gov registry record · NA
The Oral Microbiome in OSCC
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04925700: Completed NA study, sponsored by University of Iowa.
NCT04925700 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925700, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
16S Genomic Profiling will be done in all recruited subjects via oral swab of pre-cancerous or cancerous oral lesion
Interventions
- DIETARY_SUPPLEMENT ProDentis Lozenge
- OTHER Placebo Lozenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2023-10-10 |
| Phase | NA |
What the finished NCT04925700 record still lists
NCT04925700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which ProDentis Lozenge is the first listed.
NCT04925700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04925700 about?
NCT04925700 is a clinical study titled "The Oral Microbiome in OSCC". 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 th...
What is the current status of trial NCT04925700?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2022-04-20. Estimated completion is 2023-10-10.
What interventions are being tested in trial NCT04925700?
The interventions under investigation include: ProDentis Lozenge (DIETARY_SUPPLEMENT), Placebo Lozenge (OTHER).
Who is sponsoring clinical trial NCT04925700?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04925700's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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