Actively Recruiting
Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-08-21
30
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
S
St. Joseph's Health Care London
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Diagnosed with rheumatoid arthritis by ACR/EULAR criteria
- Positive for RA-associated antibodies (anti-citrullinated protein/peptide antibodies and/or rheumatoid factor)
- On stable rheumatoid arthritis therapy for more than 6 months
- In remission or have low disease activity measured by DAS28
- Provides consent to participate in the study
- Healthy fecal donor with normal BMI (18.5-30), screened for transmissible agents
You will not qualify if you...
- Pregnant or breastfeeding
- Recent (last 60 days) use of high dose oral corticosteroids (>30 mg prednisone daily or equivalent), intravenous corticosteroids, biologics, or JAK inhibitors
- Diagnosis of immunodeficiency or autoimmune disease requiring immunosuppressive therapy other than RA
- Receiving systemic steroid therapy >10 mg prednisone daily or equivalent
- Received rituximab or chemotherapy within last 2 years
- Expected to need systemic or localized anti-cancer therapy during study
- History of certain malignancies unless disease free for 5 years, with some exceptions
- Use of antibiotics or antivirals in last 3 months before FMT
- Active infection requiring systemic therapy or hospitalization in last 3 months
- Chronic intestinal diseases (e.g. celiac disease, malabsorption, inflammatory bowel disease)
- Contraindications to FMT including toxic megacolon or severe food allergies
- Serious uncontrolled illnesses including severe heart, lung, liver, kidney, or psychiatric conditions
- Received live vaccine within 4 weeks before treatment
- Insulin-dependent diabetes
- Previous bariatric surgery
- Chronic neutropenia (<0.5)
- Participation in another clinical trial
- Fecal donors excluded if having metabolic diseases, gastrointestinal or liver disorders, malignancies, recent antibiotic use, hospitalization, travel to developing countries, new sexual partners, drug use, psychiatric illness, positive tests for transmissible pathogens, or consuming excess alcohol
- Participation in other clinical trials affecting fecal composition
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Actively Recruiting
Research Team
L
Lillian Barra, MD, MPH
CONTACT
J
Jeremy Burton, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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