Status:
COMPLETED
Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Memorial Sloan Kettering Cancer Center
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and damage. RA attacks the lining of the joints (synovium), causing swelling that can result in aching and throbbi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01198509
Start Date
January 1 2010
End Date
January 1 2013
Last Update
January 13 2015
Active Locations (2)
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1
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
2
Bellevue Hospital
New York, New York, United States, 10016