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New treatment option for Arthritis
Official title Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
ClinicalTrials.gov ID: NCT05790356
What this study is testing
What is Fecal Microbial transplant?
Fecal Microbial transplant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for arthritis.
Also referred to as FMT Capsules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
You likely can't 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...
- 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...
- 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
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Previous surgery to the intestine, liver or gallbladder (except remote appendectomy)
- History of any malignancy
- Use within 3 months of any antibiotics
- Hospitalization within 3 months
- Recent travel to a developing country (within 3 months).
- New Sexual Partner (within 3 months)
- Street drug use, family history of diabetes, early onset coronary disease or gastrointestinal or liver disease, colon cancer, familial malignancy
- Psychiatric history (major affective disorder, psychotic illness, ongoing use of any psychiatric medications)
- Any positive laboratory results for a transmissible pathogen
- Alcohol intake with a cut off value of \<10g/d in women and \<20g/d in men
- Currently participating in another clinical trial that may alter fecal composition.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.