Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
NCT ID: NCT05790356
Last Updated: 2024-08-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-01
Study Completion Date
2026-04-01
Brief Summary
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This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
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Detailed Description
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This is a randomized double-blind placebo-controlled proof-of-concept trial. A total of 30 RA patients will be asked to join the study. They will be randomized to receive capsular FMT + standard of care or placebo + standard of care. There will be four study visits in total: Baseline, FMT administration, 6- and 12-week follow-up visits. Follow-up visits will consist of assessment by a rheumatologist, completion of surveys, and collection of biologic samples.
Samples for the study are stool, urine and blood. Blood and fecal samples will be collected at baseline, 6 weeks and 12 weeks. Urine samples will be collected at baseline and 6 weeks.
Samples for the study are stool, urine and blood. Blood and fecal samples will be collected at baseline, 6 weeks and 12 weeks. Urine samples will be collected at baseline and 6 weeks.
Conditions
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Arthritis
Arthritis, Rheumatoid
Fecal Microbiota Transplantation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, double-blind, placebo-controlled proof-of-concept study.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Neither the participants or the investigator will know which treatment arms participants have been assigned to. This information can be obtained quickly from pharmacy if needed.
Study Groups
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Fecal Microbial Transplant
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 Type
EXPERIMENTAL
Fecal Microbial transplant
Intervention Type
DRUG
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
Placebo
Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes.
Group Type
PLACEBO_COMPARATOR
Placebo capsules
Intervention Type
OTHER
The placebo capsules will not contain FMT but will have the same appearance.
Interventions
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Fecal Microbial transplant
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
Intervention Type
DRUG
Placebo capsules
The placebo capsules will not contain FMT but will have the same appearance.
Intervention Type
OTHER
Other Intervention Names
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FMT Capsules
Placebo
Eligibility Criteria
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Inclusion 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
* 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 supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.
* 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
* 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 supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.
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
* 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 obstructive or restrictive pulmonary diseases, cirrhosis or ALT\>100, renal disease with GFR\<50 and uncontrolled psychiatric illness.
* 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
* 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 colitis), microscopic colitis, motility disorders (including gastroparesis and irritable bowel syndrome) diverticular disease
* 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.
* 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
* 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 obstructive or restrictive pulmonary diseases, cirrhosis or ALT\>100, renal disease with GFR\<50 and uncontrolled psychiatric illness.
* 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
* 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 colitis), microscopic colitis, motility disorders (including gastroparesis and irritable bowel syndrome) diverticular disease
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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St. Joseph's Health Care London
OTHER
Sponsor Role
collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lillian Barra, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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St. Joseph's Health Care London
London, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Bykerk VP, Akhavan P, Hazlewood GS, Schieir O, Dooley A, Haraoui B, Khraishi M, Leclercq SA, Legare J, Mosher DP, Pencharz J, Pope JE, Thomson J, Thorne C, Zummer M, Bombardier C; Canadian Rheumatology Association. Canadian Rheumatology Association recommendations for pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs. J Rheumatol. 2012 Aug;39(8):1559-82. doi: 10.3899/jrheum.110207. Epub 2011 Sep 15.
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Other Identifiers
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FeMiTRA01
Identifier Type: -
Identifier Source: org_study_id
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