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



Status:Completed
Conditions:Arthritis, Psoriasis, Rheumatoid Arthritis, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:January 2010
End Date:January 2012
Contact:Jose U. Scher, MD
Email:micra@nyumc.org
Phone:212-598-6513

Use our guide to learn which trials are right for you!


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.


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.

Inclusion Criteria:

- Rheumatoid Arthritis (RA) patients must meet 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 DAS28 (Disease Activity Score 28) 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 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 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: AST/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.
We found this trial at
2
sites
New York, New York 10003
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials