Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

What this study is about

This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.

Who can join (things the study team will check)

✅ You may be able to join if…

• 18-years old or older
• RA diagnosis by ACR/EULAR criteria [26]
• Positive for the RA-associated antibodies, anti-citrullinated protein/peptide antibodies (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 satisfies the following criteria will be selected from a pool of donors available in the Infectious Diseases clinic at St. Joseph's Hospital supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.

🚫 You may not be able to join if…

• Pregnant or breastfeeding
• Current or recent [in the last 60 days] exposure to high dose oral (>30 mg of prednisone daily or equivalent), IV corticosteroids, biologic therapies or JAKi.
• Patients who require inhaled steroids or local steroid injections are not excluded from the study
• Has a diagnosis of immunodeficiency (HIV, transplantation, or autoimmune disease other than RA requiring immunosuppressive therapies), or currently receiving systemic 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 therapy while on study
• Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years. NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
• Ongoing use of antibiotics/anti-virals or previous use of antibiotics/anti-virals in the last 3 months prior to the FMT procedure
• Has an active infection requiring systemic therapy or requiring hospital admission in 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, myocardial infarction, and severe cardiac arrhythmia), severe obstructive or restrictive pulmonary diseases, cirrhosis or ALT>100, renal disease with GFR<50 and uncontrolled psychiatric illness.
• Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
• 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 not limited to; gastroesophageal reflux, peptic ulcer disease, celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), microscopic colitis, motility disorders (including gastroparesis and irritable bowel syndrome) diverticular disease

+ 11 more criteria — see the full checklist in the app.

Where this trial is running

• St. Joseph's Health Care London, London, Ontario, Canada

Who to contact

Lillian Barra, MD, MPH · 519-646-6100 · Lillian.Barra@sjhc.london.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05790356.