🏛️ Verified NIH Record • Updated 2024-08-19
Fecal Microbial Transplantation for Rheumatoid Arthritis Trial (NCT05790356)
🟢 Recruiting Observational / Diagnostic 💊 Investigational Drug / Biologic Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
🩺 Plain-English Summary (8th-Grade Level)
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: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (32 items).
Location: St. Joseph's Health Care London — London, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- St. Joseph's Health Care London — London, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.