Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
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ClinicalTrials.gov Identifier: NCT01198509 |
Recruitment Status :
Completed
First Posted : September 10, 2010
Results First Posted : January 13, 2015
Last Update Posted : January 13, 2015
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Condition or disease | Intervention/treatment | Phase |
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Rheumatoid Arthritis Psoriatic Arthritis Periodontal Disease | Drug: doxycycline Drug: vancomycin | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 178 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA) |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
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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.
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Drug: doxycycline
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
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Drug: vancomycin
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. |
- Alteration of Microbiota, Alteration of T Cell Function/Activation [ Time Frame: 6 months ]
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 ]
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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Rheumatoid Arthritis (RA) patients must meet American College of Rheumatology (ACR) criteria for RA
- RA patients: duration of disease will be greater than 6 weeks and less than 2 years.
- RA patients should have a Disease Activity Score 28 (DAS28) greater than or equal to 5.
- PsA patients will be required to have disease duration and DAS28 similar to the RA patients, and to meet Moll and Wright criteria for PsA.
- Allowable medications for both groups at study entry will include: prednisone (or equivalent) 5 mg or less per day (stable dose for at least 2 months); methotrexate 15 mg or less per week (stable dose for at least 2 months); and nonsteroidal anti-inflammatory drugs (NSAIDs) at FDA-approved doses.
- Healthy controls will be age- and sex-matched individuals with no personal or family history of inflammatory arthritis.
Exclusion Criteria:
- Patients who are unable to provide informed consent.
- Pregnant or lactating women.
- Recent (<3 months prior) use of any antibiotic therapy
- Current consumption of probiotics
- Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
- Prednisone >5 mg/day or equivalent
- Use of other disease-modifying antirheumatic drugs (DMARDs) with known antibiotic properties (Gold salts, hydroxychloroquine, sulfasalazine or minocycline).
- Use of biologic DMARDs
- Known inflammatory bowel disease
- Known gastrointestinal (GI) tract neoplasm.
- Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
- Chronic unexplained diarrhea.
- Any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)
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Significant liver, renal or peptic ulcer disease, defined as:
- Liver: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN)
- Renal: Creatinine >1.5 or endstage renal disease
- Peptic ulcer disease: recent ulcer or GI bleed (within past 12 months)
- Inability or unwillingness to abstain from alcohol consumption.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198509
United States, New York | |
NYU Hospital for Joint Diseases | |
New York, New York, United States, 10003 | |
Bellevue Hospital | |
New York, New York, United States, 10016 |
Principal Investigator: | Steven B. Abramson, MD | NYU Langone Health | |
Study Director: | Jose U. Scher, MD | NYU Langone Health |
Other Publications:
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT01198509 |
Other Study ID Numbers: |
09-0658 RC2AR058986 ( U.S. NIH Grant/Contract ) |
First Posted: | September 10, 2010 Key Record Dates |
Results First Posted: | January 13, 2015 |
Last Update Posted: | January 13, 2015 |
Last Verified: | December 2014 |
rheumatoid arthritis psoriatic arthritis periodontitis microbiota microbiome |
vancomycin doxycycline T cell Th17 |
Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic Periodontal Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Mouth Diseases Stomatognathic Diseases Vancomycin Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |