~4 spots leftby Aug 2025

Fecal Microbial Transplantation for Rheumatoid Arthritis

(FeMiTRA Trial)

Recruiting in Palo Alto (17 mi)
LB
Overseen byLillian Barra, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lawson Health Research Institute
Must not be taking: Corticosteroids, Biologics, JAKi, Antibiotics
Disqualifiers: Pregnancy, Immunodeficiency, Cancer, Diabetes, others
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your rheumatoid arthritis therapy has been stable for more than 6 months. If you are on high-dose steroids, biologic therapies, or certain other medications, you may not be eligible to participate.

What data supports the effectiveness of this treatment for rheumatoid arthritis?

There is a case report of a patient with difficult-to-treat rheumatoid arthritis who showed improvement after receiving fecal microbiota transplantation (FMT), suggesting it might be helpful for this condition.12345

Is fecal microbiota transplantation (FMT) generally safe for humans?

FMT is generally considered safe, especially with thorough donor screening and testing. Most short-term risks are related to the delivery method, like colonoscopy, while long-term risks are less understood but have not shown harm in follow-ups. Rarely, it has been linked to serious outcomes, such as the transmission of antibiotic-resistant bacteria.12678

How does fecal microbial transplantation differ from other treatments for rheumatoid arthritis?

Fecal microbial transplantation (FMT) is unique because it involves transferring stool from a healthy donor to a patient to restore gut bacteria balance, which is different from traditional rheumatoid arthritis treatments that typically involve drugs or biologics targeting the immune system. This approach is novel as it focuses on altering the gut microbiome, which may influence inflammation and immune responses in the body.910111213

Research Team

LB

Lillian Barra, MD, MPH

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

This trial is for adults over 18 with rheumatoid arthritis, who have specific RA antibodies and are in remission or have low disease activity. They must be on stable RA therapy for more than 6 months and agree to the study's terms. A healthy donor with a normal BMI will provide stool samples.

Inclusion Criteria

I am 18 years old or older.
RA diagnosis by ACR/EULAR criteria
Consents to study
See 3 more

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks.
Anaphylactic allergic reactions to food
I have had weight loss surgery in the past.
See 15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline assessments including collection of stool, urine, and blood samples

1 day
1 visit (in-person)

Treatment

Participants receive either FMT or placebo capsules orally

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with assessments at 6 and 12 weeks

12 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Fecal Microbial transplant (Microbiome Therapy)
  • Placebo capsules (Other)
Trial OverviewThe trial tests if swallowing capsules containing stool from healthy donors (fecal microbial transplant) can benefit rheumatoid arthritis patients compared to placebo capsules without active ingredients.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fecal Microbial TransplantExperimental Treatment1 Intervention
Participants will be administered 35-40 FMT capsules orally with water, for a total dose of 80-100g. This will only occur once and takes approximately 30 minutes.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
St. Joseph's Health Care LondonLondon, Canada
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Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler profile image

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+
Dr. Alex Barron profile image

Dr. Alex Barron

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Medical Officer since 2023

MD from Western University

David Musyj profile image

David Musyj

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Executive Officer

Physiotherapy degree

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+
Lisa Porter profile image

Lisa Porter

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler profile image

Roy Butler

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+
Roy Butler profile image

Roy Butler

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik profile image

Dr. Cindy Hutnik

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

MD, PhD

St. Joseph's Health Care London

Collaborator

Trials
28
Recruited
2,500+

Findings from Research

This case report presents the first known instance of using fecal microbiota transplantation (FMT) to treat a patient with refractory rheumatoid arthritis (RA), suggesting a novel therapeutic approach.
The successful treatment indicates that FMT may have a beneficial effect on RA, warranting further investigation into its efficacy and safety for this condition.
Fecal microbiota transplantation for rheumatoid arthritis: A case report.Zeng, J., Peng, L., Zheng, W., et al.[2021]
Probiotics have been well tolerated in patients with rheumatic diseases, but most studies have not shown significant clinical benefits from their use.
Fecal microbial transplantation (FMT) has shown mixed results, with one study indicating minimal benefit and another suggesting worsening symptoms compared to sham treatment, highlighting the need for further research in this area.
Therapeutic alteration of the microbiota in rheumatic diseases: Hype or potential?Stoll, ML.[2023]
A patient with refractory ankylosing spondylitis and ulcerative colitis showed significant improvement after undergoing three fecal microbiota transplantations (FMTs), especially noted one week after the first transplant.
The changes in fecal microbiota correlated with the improvements in both ankylosing spondylitis and ulcerative colitis symptoms, suggesting that targeting gut microbiota may be a promising alternative therapy for AS, although further studies are needed to confirm these findings.
Case report: Fecal microbiota transplantation in refractory ankylosing spondylitis.Wang, L., Wei, Z., Pan, F., et al.[2023]

References

Fecal microbiota transplantation for rheumatoid arthritis: A case report. [2021]
Experiences and perceptions of patients with psoriatic arthritis participating in a trial of faecal microbiota transplantation: a nested qualitative study. [2021]
Therapeutic alteration of the microbiota in rheumatic diseases: Hype or potential? [2023]
Case report: Fecal microbiota transplantation in refractory ankylosing spondylitis. [2023]
Efficacy and safety of faecal microbiota transplantation in patients with psoriatic arthritis: protocol for a 6-month, double-blind, randomised, placebo-controlled trial. [2019]
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]
Regulation, risk and safety of Faecal Microbiota Transplant. [2021]
Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. [2022]
Future strategies in hematopoietic stem cell transplantation for rheumatoid arthritis. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Biologic agents in rheumatoid arthritis: an update for managed care professionals. [2023]
Apparent cure of rheumatoid arthritis by bone marrow transplantation. [2016]
Allogeneic intra-bone marrow transplantation prevents rheumatoid arthritis in SKG/Jcl mice. [2010]
Nonmyeloablative allogeneic hematopoietic cell transplants: any role for rheumatoid arthritis? [2021]