Oral Metagenomic Biomarkers in Rheumatoid Arthritis
NCT02544334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92
Last updated 2019-08-12
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.
Conditions
Interventions
- PROCEDURE
-
Dental Plaque
All participants will have dental plaque removed from different tooth surfaces for supragingival.
- OTHER
-
Multi-dimensional health assessment questionnaire (MDHAQ)
The RA groups will receive the multi-dimensional health assessment questionnaire (MDHAQ) for physical function, pain, and global status.
- OTHER
-
Saliva Collection
All participants will have a saliva collection.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
VA Medical Center-Gainesville
collaborator FED -
University of Florida
lead OTHER
Principal Investigators
-
Michael R Bubb, MD · University of Florida
-
Edward K Chan, Ph.D. · University of Florida
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2019-08-08
- Completion
- 2019-08-08
Countries
- United States
Study Locations
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