Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)

Completed · Not applicable

Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis, Periodontal Disease

In brief

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 throbbing, and eventually deformity. Even though there have been many advances in the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors still do not know what causes this inflammation in joints. It is likely that RA occurs as a result of a complex combination of factors, including a person's genes; lifestyle choices, such as smoking and diet; and things in a person's environment, including bacteria or viruses. This study investigates the hypothesis that bacteria living in a person's mouth and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid Arthritis. The investigators believe that by killing those bacteria with antibiotics, they might be able to understand how the immune system works and, maybe, what causes RA.

Key facts

Study ID

NCT01198509

Run by

NYU Langone Health

People needed

178

Starts

2010-01-01

Expected to finish

2013-01-01

Last updated by the study team

2015-01-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NYU Hospital for Joint Diseases — New York, New York, United States
• Bellevue Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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