Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)|
- Alteration of Microbiota, Alteration of T Cell Function/Activation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Results are reported as number of participants who experienced changes in oral/intestinal microbiota, T cell function/activation.
Methods/criteria to assess change in microbiota: change in relative abundance of microorganisms at genus and species level (as assessed high-throughput 16S rDNA sequencing).
Methods/criteria to assess change in T cell function/activation: change in percentage of inhibition of regulatory T cells as measured by interferon gamma levels in in-vitro assays.
- Mean Units Change in DAS28 From Baseline to 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
DAS28 (disease activity score with 28 joint count). Possible score range: 0 to 10. This is a composite index calculated from 4 measures: two from a physician (28 tender joint count, 28 swollen joint count), one from the patient (patient global estimate of disease activity), and one laboratory biomarker (erythrocyte sedimentation rate or ESR). A score of 0 represents best possible health status (no apparent disease activity) and 10 represents worst possible.
The outcome is reported as mean change in DAS28 score from baseline to 6 months. The mean changes reported are negative values for downward change in score (i.e., improvement in health status).
|Study Start Date:||January 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Rheumatoid Arthritis (RA) - doxycycline
Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline - 100 mg twice per day, for 2 months
Other Name: Vibramycin
Active Comparator: Rheumatoid Arthritis (RA) - vancomycin
Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin, 250 mg four times a day, for 2 weeks
Other Name: Vancocin
No Intervention: RA, PsA, healthy
Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.
Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198509
|United States, New York|
|New York, New York, United States, 10016|
|NYU Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|Principal Investigator:||Steven B. Abramson, MD||New York University School of Medicine|
|Study Director:||Jose U. Scher, MD||New York University School of Medicine|