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NCT02544334 · ClinicalTrials.gov registry record
Oral Metagenomic Biomarkers in Rheumatoid Arthritis
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 92
- Enrollment target
NCT02544334 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 92 participants.
The verdict
NCT02544334 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
Study Summary
Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2 million in the United States. The role of environmental factors in modulating autoimmunity pathogenesis has been clearly described and yet the specific mechanisms of action remain poorly understood. A growing body of evidence implicates microbiota of mucosal surfaces in the development of autoimmune disorders. Various studies have clearly linked RA to periodontal disease. The latter is linked to the red-complex that includes the oral bacterium Porphyromonas gingivalis. And yet there has not been a systematic analysis of the oral microbiota in RA to determine whether there are specific markers for P. gingivalis (and other oral bacteria) that are linked to RA. In this study, the investigators will characterize oral microbial composition (microbiome) and gene content (metagenome) of DNA isolated from oral samples obtained from patients with (i) early stage RA prior to biologics treatments and (ii) subsets of RA patients who are responsive or unresponsive to anti-TNF-alpha therapy. The innovative aspect of this study is going beyond the identification of oral bacterial species, to the level of strains and genes that are associated with these groups. The overall hypothesis is that oral microbial variation exists between individuals that influences development of autoimmunity and autoimmune disease.
Interventions
- OTHER Saliva Collection
- PROCEDURE Dental Plaque
- OTHER Multi-dimensional health assessment questionnaire (MDHAQ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2016-05 |
| Est. Completion | 2019-08-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02544334
The ClinicalTrials.gov registry entry for NCT02544334 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Saliva Collection is the first listed.
NCT02544334 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02544334 about?
NCT02544334 is a clinical study titled "Oral Metagenomic Biomarkers in Rheumatoid Arthritis". Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2 million in the United States. The role of environmental factors in modulating autoimmunity pathogenesis has been clearly described and yet the specific mechanisms of action remain poorly understood. A growin...
What is the current status of trial NCT02544334?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2016-05. Estimated completion is 2019-08-08.
What interventions are being tested in trial NCT02544334?
The interventions under investigation include: Saliva Collection (OTHER), Dental Plaque (PROCEDURE), Multi-dimensional health assessment questionnaire (MDHAQ) (OTHER).
Who is sponsoring clinical trial NCT02544334?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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