Oral Metagenomic Biomarkers in Rheumatoid Arthritis

NCT02544334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2019-08-12

No results posted yet for this 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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544334 on ClinicalTrials.gov