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WHAT IS THE PURPOSE OF THIS that perhaps there is an infectious bacteria STUDY? (in your mouth or intestine) that actually causes or worsens the in your Even though there have been many advances in . the treatment of RA, psoriatic (PsA), IS YOUR ARTHRITIS and other , doctors still do WHAT DON’T WE KNOW ABOUT THE not know what causes the inflammation in your USE OF ANTIBIOTICS TO TREAT ACTUALLY CAUSED joints. For decades, many theories have been RHEUMATIC DISEASE? proposed, but none of them have been proven Traditionally when people get an infection, BY BACTERIA? right. Currently, there's no cure for RA. It's the bacteria that cause it can be identified by likely that RA occurs as a result of a complex performing a “culture” of the affected , combination of factors, including your genes, tissue or body fluid. For instance, when If you think so, this study may be your lifestyle choices, such as smoking and diet, someone gets a urinary tract infection, a and things in your environment, such as bacteria for you. doctor orders a urinary culture. After a few or viruses. days, and if a bacteria “grows” in a special

mix of nutrients, a specific antibiotic is WHAT IS RHEUMATOID ARTHRITIS We actually think that bacteria that live in prescribed to fight the infection. (RA)? your mouth and intestine are responsible, at

least in part, for the development of your Rheumatoid arthritis (RA) is an However, most of the bacteria that live in our Arthritis. We believe that by killing those inflammatory form of arthritis that causes mouths (teeth and gums) and in our intestines bacteria with antibiotics, we might be able to and damage. RA attacks the cannot be identified by these traditional understand how works and lining of your joints (synovium), causing “cultures.” For that reason, arthritis maybe what causes arthritis. swelling that can result in aching and investigators have been unable to understand throbbing, and eventually deformity. which bacteria, if any, are being killed by the Sometimes RA symptoms make even the WHAT DO WE KNOW ABOUT THE USE antibiotics we use. In fact, some have simplest activities — such as opening a jar OF ANTIBIOTICS TO TREAT suggested that these antibiotics have mostly or taking a walk — difficult to manage. RHEUMATIC DISEASE? anti-inflammatory properties and that their mode of action is not related to the WHAT ARE THE SIGNS AND Based on scientific studies, clinical trials and elimination of bacteria. We would like to SYMPTOMS OF RA? patient surveys, we know that certain antibiotics investigate this important matter further. (such as , , of rheumatoid arthritis may include: and others) slow or stop the • Joint pain progression of rheumatoid arthritis, ease pain, HOW WOULD YOU KNOW WHICH • Joint swelling lessen stiffness, diminish swollen joints and BACTERIA MAY BE ASSOCIATED • Joints that are tender to the touch enhance the quality of life. Several of them are WITH RA? actually approved by the Food and Drug • Red and puffy New genetic technology can help us identify Administration (FDA) for the treatment of RA. • Firm bumps of tissue under the skin these bacteria. There are studies in humans

on your arms (rheumatoid nodules) and in mice that show a link between the While conventional therapy uses • presence of certain bacteria in the gut and the aimed at controlling or suppressing the • Morning stiffness that lasts at least development of arthritis. Using similar symptoms — the so-called Disease-Modifying 30 minutes techniques, we want to find out if people with Anti Rheumatic Drugs or DMARDs (including • RA have different bacteria than people with , , Enbrel, Humira, • PsA and healthy people. and others) — antibiotics are used with the idea Then, we want to test this idea by giving antibiotics to patients with RA (on top of We will then make a follow up appointment VISIT D, E and F. One month after VISIT C, their regular medications) and obtain within 2 weeks where your first stool and oral you will be finished with your study samples from blood, dental cleanings, urine samples will be taken and where you will be medications. You will come back to see your and stools to look for variations in the actually given the antibiotics (VISIT B). regular doctor as usual (every 6-8 weeks). For expression of genes, immune cells, proteins, these three appointments, we will work together enzymes, and oral and intestinal bacteria. VISIT B. This will be what we call the with your doctor so you do not spend too much “Baseline Visit.” In this important visit, the most extra time. The idea is that you get your regular HOW CAN I TAKE PART IN THIS time-consuming one, we will ask you to come to medications for RA and, without your STUDY? your appointment with your stool sample. A antibiotics, we continue to collect stool samples. If you agree to participate, we will first ask group of 4 people will be guiding you for a few you several questions regarding the status of hours of your day. We will meet you at the NYU HOW WOULD I KNOW HOW TO your arthritis, the medications you use or College of Dentistry – Bluestone Center for Clinical Research, at 421 1st Ave. (between 24th COLLECT MY STOOL SAMPLES? have used in the recent past, your social and th nd dietary habits, and your medical and and 25 street), 2 Floor – Clinic 2W, New We have prepared an instruction sheet with surgical history. If your answers tell us that York. We will receive the questionnaires you pictures to explain the process better. you are the right patient for our study, we have filled out, the stool samples, and will go will go over a consent form which describes over a brief physical exam. A dental hygienist IF I HAVE A QUESTION ABOUT THE in more detail how we will study your will look at your gums and obtain a few STUDY, THE ANTIBIOTICS OR EVEN intestinal and mouth bacteria, the immune samples. You will get a dental cleaning for free ABOUT APPOINTMENTS, WHO SHOULD cells in your blood and other genes, if necessary. We will collect blood and urine and I CONTACT? enzymes and proteins that tell us about your give you another stool collection kit for you to disease status. bring to your next regular appointment (VISIT You can contact us at any time (24/7) at the C). Before you leave, we will assign you to a following: “treatment group.” You will be given a 2-month • Phone No.: 212-598-6513 SAY I QUALIFY FOR THIS STUDY supply of either Vancomycin, Doxycycline or AND I AGREE TO PARTICIPATE — • E-mail: [email protected] placebo (an inactive pill with no ) for WHAT ARE THE NEXT STEPS? you to take. You will not know what you are VISIT A. First, we will review your history taking, so the results of the study are not WILL I GET REIMBURSED FOR MY of arthritis in more detail and your personal influenced by what you think. TIME AND TRAVEL EXPENSES? information will be taken; we will make We will provide lunch for you at VISIT B. At sure your blood work, X-rays, PPD test (for VISIT C. One month after VISIT B, you will VISIT D you will receive a reimbursement for ) and other blood tests related to come back to see your regular doctor as usual. your time and travel expenses. your health are up-to-date. A thorough You will be asked questions about the study physical exam will be performed (including medications you are taking and how you are a formal count of your swollen/tender feeling. If you need a change in pain medication joints) and a questionnaire of your well- for your arthritis, your doctor can prescribe it for being will be filled out. You will then be you. We will collect blood and urine and give you another stool collection kit. Microbiome Center for assigned to one of three treatment groups. and (MiCRA) You will either receive a type of antibiotics on top of your current RA medications or you will only continue with RA meds (with 301 East 17th Street, Room 1611. New York, NY 10003 no antibiotics). Phone: (212) 598-6513 E-mail: [email protected]