Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05790356

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

34 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

Researchers are studying the effects of fecal microbial transplant (FMT) capsules from healthy donors on patients with rheumatoid arthritis (RA). This randomized, double-blind, placebo-controlled trial aims to evaluate changes in gut bacteria and intestinal health, as well as RA-associated antibodies, in 30 RA patients who meet specific criteria such as stable therapy and low disease activity. The study is sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Participants are randomly assigned to receive either a single dose of 35-40 FMT capsules or placebo capsules, both taken orally with water. The FMT dose totals 80-100 grams and the administration takes about 30 minutes. All participants continue their standard RA care throughout the trial. The study includes four visits: baseline, treatment, and follow-ups at 6 and 12 weeks. During these visits, patients will be assessed by rheumatologists, complete surveys, and provide biological samples including stool, urine, and blood. Samples are collected at baseline, 6 weeks, and 12 weeks depending on type. The main outcomes measured include changes in intestinal permeability and RA-related antibodies, as well as any adverse events. Secondary outcomes include changes in gut microbial composition and C-reactive protein levels. The study will conclude by April 2026.

CONDITIONS

Brief Title

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Diagnosed with rheumatoid arthritis by ACR/EULAR criteria
  • Positive for RA-associated antibodies (ACPA and/or rheumatoid factor)
  • Stable rheumatoid arthritis therapy for more than 6 months
  • In remission or low disease activity by DAS28
  • Provides consent to participate in the study
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Recent exposure (last 60 days) to high-dose oral corticosteroids (>30 mg prednisone daily or equivalent), IV corticosteroids, biologic therapies, or JAK inhibitors
  • Diagnosed immunodeficiency or autoimmune disease other than RA requiring immunosuppressive therapies
  • Currently receiving systemic steroid therapy (>10 mg prednisone daily or equivalent)
  • Received rituximab or chemotherapy in the last 2 years
  • Expected to require other systemic or localized anti-neoplastic therapy during the study
  • History of hematologic malignancy, primary brain tumor, sarcoma, or other primary solid tumors unless disease-free for 5 years
  • Ongoing or recent (last 3 months) use of antibiotics or antivirals
  • Active infection requiring systemic therapy or hospitalization in last 3 months
  • Chronic intestinal diseases such as celiac disease, malabsorption, colonic tumor, or inflammatory bowel disease
  • Absolute contraindications to FMT administration
  • Toxic megacolon
  • Anaphylactic allergic reactions to certain foods (shellfish, nuts, seafood, eggs)
  • Serious uncontrolled illnesses including cardiovascular, pulmonary, liver, renal, or psychiatric conditions
  • Received live vaccine within 4 weeks prior to treatment
  • Insulin-dependent diabetes
  • Previous bariatric surgery
  • Chronic neutropenia (<0.5)
  • Currently participating in another clinical trial that may affect fecal composition

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single administration visit

Participants receive either fecal microbial transplant capsules or placebo capsules along with standard care.

1 visit (in-person)

Follow-up

Duration - 12 weeks

Participants are assessed by a rheumatologist, complete surveys, and provide stool, urine, and blood samples to monitor treatment effects.

2 visits at 6 and 12 weeks post-treatment

Trial Site Locations

Total: 1 location

1

St. Joseph's Health Care London

London, Ontario, Canada, N6A 4V2

Actively Recruiting

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Research Team

L

Lillian Barra, MD, MPH

J

Jeremy Burton, PhD

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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Published Research Related To This Trial

Canadian Rheumatology Association recommendations for pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs.

Vivian P Bykerk, Pooneh Akhavan, Glen S Hazlewood...

https://pubmed.ncbi.nlm.nih.gov/21921096

Heterogeneous Disease Trajectories Explain Variable Radiographic, Function and Quality of Life Outcomes in the Canadian Early Arthritis Cohort (CATCH).

Cheryl Barnabe, Ye Sun, Gilles Boire...

https://pubmed.ncbi.nlm.nih.gov/26301589

Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety.

Claire Bombardier, Glen S Hazlewood, Pooneh Akhavan...

https://pubmed.ncbi.nlm.nih.gov/22707613

Perspectives of patients, first-degree relatives and rheumatologists on preventive treatments for rheumatoid arthritis: a qualitative analysis.

Sarah Munro, Luke Spooner, Katherine Milbers...

https://pubmed.ncbi.nlm.nih.gov/30886969

Qualitative Study of Treatment Preferences for Rheumatoid Arthritis and Pharmacotherapy Acceptance: Indigenous Patient Perspectives.

Adalberto Loyola-Sanchez, Glen Hazlewood, Lynden Crowshoe...

https://pubmed.ncbi.nlm.nih.gov/30821924

Treatment Satisfaction, Patient Preferences, and the Impact of Suboptimal Disease Control in a Large International Rheumatoid Arthritis Cohort: SENSE Study.

Peter C Taylor, Codrina Ancuta, Orsolya Nagy...

https://pubmed.ncbi.nlm.nih.gov/33633444