Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
If you would like to participate in this study, we will first ask you several questions
regarding the status of your arthritis, the medications you use or have used in the recent
past, your social and dietary habits, and your medical and surgical history. If your answers
tell us that you are the right patient for our study, we will go over a consent form which
describes in more detail how we will study your intestinal and mouth bacteria, the immune
cells in your blood and other genes, enzymes and proteins that tell us about your disease
status.
If you have Psoriatic Arthritis (PsA) or are healthy with no history of arthritis, and would
like to participate in this study, your participation would involve only one or two visits,
and no treatment.
If you have Rheumatoid Arthritis (RA), your participation would involve six visits, and you
would be randomly assigned to receive treatment with the antibiotic doxycycline, or the
antibiotic vancomycin, or no antibiotic treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Alteration of microbiota, T cell function and activation
Oral and intestinal microbiota, and T cell function and activation, will be assessed at baseline, and at 1, 2, 3, 4 and 5 months after baseline, to determine whether changes are associated with vancomycin treatment versus doxycycline treatment versus no treatment.
6 months
No
Steven B. Abramson, MD
Principal Investigator
New York University School of Medicine
United States: Institutional Review Board
09-0658
NCT01198509
January 2010
January 2013
Name | Location |
---|---|
Bellevue Hospital | New York, New York 10016 |
NYU Hospital for Joint Diseases | New York, New York 10003 |