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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: Completed study, sponsored by University of Florida.

NCT02544334 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 92 participants. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A Wilcoxon rank-sum test will be computed on each profile to identify differential metagenomic gene content between each pair of groups (RA patients and controls). The potential microbial functional roles of the KEGG orthologues and eggnog orthologue groups markers in the oral microbiota of RA patients will also be assessed. All results will be corrected for multiple testing using a false discovery rate approach.

Interventions

  • OTHER Saliva Collection
  • PROCEDURE Dental Plaque
  • OTHER Multi-dimensional health assessment questionnaire (MDHAQ)

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2016-05
Est. Completion 2019-08-08
University of Florida

1,106 total trials

What the finished NCT02544334 record still lists

NCT02544334 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target.

The record links to 0 conditions, and to 3 interventions - of which Saliva Collection is the first listed.

NCT02544334 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT02544334, the US trial registry maintained by the National Library of Medicine. NCT02544334 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.