Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

Inclusion Criteria:

• 18-years old or older

• RA diagnosis by ACR/EULAR criteria [26]

• Positive for the RA-associated antibodies, anti-citrullinated protein/peptideantibodies (ACPA) and/or rheumatoid factor (RF)

• Stable RA therapy > 6 months

• Patient in remission or low disease activity by DAS28

• Consents to study

Fecal Donor Inclusion Criteria:

• A healthy donor who has a normal body mass index (BMI of 18.5-30) and who satisfiesthe following criteria will be selected from a pool of donors available in theInfectious Diseases clinic at St. Joseph's Hospital supervised by Dr. Silverman andscreened for all transmissible agents. at the Microbiology and Immunology lab at St.Joseph's Hospital under Dr. Silverman for the study and screened for transmissibleagents.

Exclusion Criteria:

• Pregnant or breastfeeding

• Current or recent [in the last 60 days] exposure to high dose oral (>30 mg ofprednisone daily or equivalent), IV corticosteroids, biologic therapies or JAKi.

• Patients who require inhaled steroids or local steroid injections are not excludedfrom the study

• Has a diagnosis of immunodeficiency (HIV, transplantation, or autoimmune diseaseother than RA requiring immunosuppressive therapies), or currently receivingsystemic steroid therapy (>10 mg prednisone daily or equivalent)

• Received rituximab or other chemotherapeutic agent in the last 2 years.

• Expected to require any other form of systemic or localized anti-neoplastic therapywhile on study

• Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, orof another primary solid tumor, unless the patient has undergone potentiallycurative therapy with no evidence of that disease for five years. NOTE: This timerequirement also does not apply to patients who underwent successful definitiveresection of basal or squamous cell carcinoma of the skin, superficial bladdercancer, in situ cancers including cervical cancer, breast cancer, melanoma, or otherin situ cancers.

• Ongoing use of antibiotics/anti-virals or previous use of antibiotics/anti-virals inthe last 3 months prior to the FMT procedure

• Has an active infection requiring systemic therapy or requiring hospital admissionin last 3 months.

• Presence of a chronic intestinal disease (e.g. Celiac disease, malabsorption,colonic tumor, IBD)

• Presence of absolute contra-indications to FMT administration

• Toxic megacolon

• Anaphylactic allergic reactions to food (e.g. shellfish, nuts, seafood, eggs)

• Has serious uncontrolled concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardialinfarction, and severe cardiac arrhythmia), severe obstructive or restrictivepulmonary diseases, cirrhosis or ALT>100, renal disease with GFR<50 and uncontrolledpsychiatric illness.

• Patient has received a live vaccine within 4 weeks prior to the first dose oftreatment

• Insulin-dependent diabetes

• Previous bariatric surgery

• Chronic neutropenia (<0.5) Currently participating in another clinical trial

Fecal Donor Exclusion Criteria:

• Any underlying metabolic disease including; hypertension, hyperlipidemia, diabetes,insulin insensitivity, atherosclerosis

• A history of any gastrointestinal or liver disorders or cancers. Including but notlimited to; gastroesophageal reflux, peptic ulcer disease, celiac disease,inflammatory bowel disease (Crohn's disease or ulcerative colitis), microscopiccolitis, motility disorders (including gastroparesis and irritable bowel syndrome)diverticular disease

• Previous surgery to the intestine, liver or gallbladder (except remote appendectomy)

• History of any malignancy

• Use within 3 months of any antibiotics

• Hospitalization within 3 months

• Recent travel to a developing country (within 3 months).

• New Sexual Partner (within 3 months)

• Street drug use, family history of diabetes, early onset coronary disease orgastrointestinal or liver disease, colon cancer, familial malignancy

• Psychiatric history (major affective disorder, psychotic illness, ongoing use of anypsychiatric medications)

• Any positive laboratory results for a transmissible pathogen

• Alcohol intake with a cut off value of <10g/d in women and <20g/d in men

• Currently participating in another clinical trial that may alter fecal composition.