Oral Metagenomic Biomarkers in Rheumatoid Arthritis
Completed
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT02544334
- Run by
- University of Florida
- People needed
- 92
- Starts
- 2016-05-01
- Expected to finish
- 2019-08-08
- Last updated by the study team
- 2019-08-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- with at least 10 natural uncrowned teeth (excluding third molars) must be present.
You may not qualify if…
- have less than 10 teeth;
- have been treated with antibiotics within the past 3 months, including patients that require antibiotic prophylaxis prior to dental treatment;
- are immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy);
- participate in another clinical study involving the use of dental products one week prior to the start of the washout period or during the study period; and
- are unwilling or unable to provide informed consent and follow the collection instructions.
Where it is running
- University of Florida College of Dentistry-Periodontics — Gainesville, Florida, United States
- Randall Malcom VA Medical Center — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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