ArthritisFeMiTRANCT05790356
Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
A study testing Fecal Microbial transplant in people with Arthritis and Arthritis, Rheumatoid, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Arthritis, Rheumatoid, Fecal Microbiota Transplantation
- What is being tested?
- Fecal Microbial transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Inclusion Criteria:
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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
- 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 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Arden Lawson, BMSc, 519-646-6100 ext. 42570, arden.lawson@sjhc.london.on.ca
Alex Roa, MLA/T, 519-646-6100 ext. 42696, alexandria.roaagudelo@sjhc.london.on.ca
About this study
This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
Read the detailed description
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.
- Being tested
- Fecal Microbial transplant, Placebo capsules
- Keywords
- Arthritis, Rheumatoid, Rheumatoid Arthritis, clinical trial, fecal matter transplantation, fecal matter transplant, faecal, autoimmune, proof of concept
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial transplantDrug
Also called FMT Capsules
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
Placebo capsulesOther
Also called Placebo
The placebo capsules will not contain FMT but will have the same appearance.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbial Transplant | Experimental | 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. Receives: Drug: Fecal Microbial transplant |
| Placebo | Placebo comparator | Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes. Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intestinal Permeability
A blood sample will be collected for bacterial DNA analysis.
Measured: Baseline and 6 weeks
Change in Intestinal Permeability
A urine sample will be collected to measure the lactulose to mannitol ratio.
Measured: Baseline and 6 weeks
Change in RA-associated autoantibodies
A blood sample will be collected to measure RA-associated autoantibodies.
Measured: Baseline, 6 weeks and 12 weeks
Adverse Events
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Measured: Baseline
Adverse Events
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Measured: FMT treatment visit
Adverse Events
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Measured: 6 weeks post-treatment
Adverse Events
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Measured: 12 weeks post-treatment
Secondary outcomes (2)
Change in Fecal Microbial Composition
Stool samples will be collected to determine fecal microbial composition using 16S-RNA sequencing.
Measured: Baseline, 6 weeks and 12 weeks
Change in C-Reactive Protein
Blood sample will be collected to measure CRP levels.
Measured: Baseline, 6 weeks and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled proof-of-concept study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor
- Investigators
- Lillian Barra, MD, MPH, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790356
- Sponsor's protocol ID
- FeMiTRA01
- Acronym
- FeMiTRA
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21921096Barnabe C, Sun Y, Boire G, Hitchon CA, Haraoui B, Thorne JC, Tin D, van der Heijde D, Curtis JR, Jamal S, Pope JE, Keystone EC, Bartlett S, Bykerk VP; CATCH Investigators. Heterogeneous Disease Trajectories Explain Variable Radiographic, Function and Quality of Life Outcomes in the Canadian Early Arthritis Cohort (CATCH). PLoS One. 2015 Aug 24;10(8):e0135327. doi: 10.1371/journal.pone.0135327. eCollection 2015.
PubMed 26301589Bombardier C, Hazlewood GS, Akhavan P, Schieir O, Dooley A, Haraoui B, Khraishi M, Leclercq SA, Legare J, Mosher DP, Pencharz J, Pope JE, Thomson J, Thorne C, Zummer M, Gardam MA, Askling J, Bykerk V; Canadian Rheumatology Association. Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety. J Rheumatol. 2012 Aug;39(8):1583-602. doi: 10.3899/jrheum.120165. Epub 2012 Jun 15.
PubMed 22707613Munro S, Spooner L, Milbers K, Hudson M, Koehn C, Harrison M. Perspectives of patients, first-degree relatives and rheumatologists on preventive treatments for rheumatoid arthritis: a qualitative analysis. BMC Rheumatol. 2018 Jul 5;2:18. doi: 10.1186/s41927-018-0026-7. eCollection 2018.
PubMed 30886969Loyola-Sanchez A, Hazlewood G, Crowshoe L, Linkert T, Hull PM, Marshall D, Barnabe C. Qualitative Study of Treatment Preferences for Rheumatoid Arthritis and Pharmacotherapy Acceptance: Indigenous Patient Perspectives. Arthritis Care Res (Hoboken). 2020 Apr;72(4):544-552. doi: 10.1002/acr.23869.
PubMed 30821924Taylor PC, Ancuta C, Nagy O, de la Vega MC, Gordeev A, Jankova R, Kalyoncu U, Lagunes-Galindo I, Morovic-Vergles J, de Souza MPGUES, Rojkovich B, Sidiropoulos P, Kawakami A. Treatment Satisfaction, Patient Preferences, and the Impact of Suboptimal Disease Control in a Large International Rheumatoid Arthritis Cohort: SENSE Study. Patient Prefer Adherence. 2021 Feb 17;15:359-373. doi: 10.2147/PPA.S289692. eCollection 2021.
PubMed 33633444Deane KD, Holers VM. Rheumatoid Arthritis Pathogenesis, Prediction, and Prevention: An Emerging Paradigm Shift. Arthritis Rheumatol. 2021 Feb;73(2):181-193. doi: 10.1002/art.41417. Epub 2020 Dec 8.
PubMed 32602263Wilson AS, Koller KR, Ramaboli MC, Nesengani LT, Ocvirk S, Chen C, Flanagan CA, Sapp FR, Merritt ZT, Bhatti F, Thomas TK, O'Keefe SJD. Diet and the Human Gut Microbiome: An International Review. Dig Dis Sci. 2020 Mar;65(3):723-740. doi: 10.1007/s10620-020-06112-w.
PubMed 32060812Zaiss MM, Joyce Wu HJ, Mauro D, Schett G, Ciccia F. The gut-joint axis in rheumatoid arthritis. Nat Rev Rheumatol. 2021 Apr;17(4):224-237. doi: 10.1038/s41584-021-00585-3. Epub 2021 Mar 5.
PubMed 33674813Scher JU, Sczesnak A, Longman RS, Segata N, Ubeda C, Bielski C, Rostron T, Cerundolo V, Pamer EG, Abramson SB, Huttenhower C, Littman DR. Expansion of intestinal Prevotella copri correlates with enhanced susceptibility to arthritis. Elife. 2013 Nov 5;2:e01202. doi: 10.7554/eLife.01202.
PubMed 24192039Mohammed AT, Khattab M, Ahmed AM, Turk T, Sakr N, M Khalil A, Abdelhalim M, Sawaf B, Hirayama K, Huy NT. The therapeutic effect of probiotics on rheumatoid arthritis: a systematic review and meta-analysis of randomized control trials. Clin Rheumatol. 2017 Dec;36(12):2697-2707. doi: 10.1007/s10067-017-3814-3. Epub 2017 Sep 15.
PubMed 28914373Meyers S, Shih J, Neher JO, Safranek S. Clinical Inquiries: How effective and safe is fecal microbial transplant in preventing C difficile recurrence? J Fam Pract. 2018 Jun;67(6):386-388.
PubMed 29879241Claytor JD, El-Nachef N. Fecal microbial transplant for inflammatory bowel disease. Curr Opin Clin Nutr Metab Care. 2020 Sep;23(5):355-360. doi: 10.1097/MCO.0000000000000676.
PubMed 32618725Chapman BC, Moore HB, Overbey DM, Morton AP, Harnke B, Gerich ME, Vogel JD. Fecal microbiota transplant in patients with Clostridium difficile infection: A systematic review. J Trauma Acute Care Surg. 2016 Oct;81(4):756-64. doi: 10.1097/TA.0000000000001195.
PubMed 27648772Sun D, Li W, Li S, Cen Y, Xu Q, Li Y, Sun Y, Qi Y, Lin Y, Yang T, Xu P, Lu Q. Fecal Microbiota Transplantation as a Novel Therapy for Ulcerative Colitis: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 Jun;95(23):e3765. doi: 10.1097/MD.0000000000003765.
PubMed 27281075
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation for Rheumatoid Arthritis Trial
- ClinicalTrials.gov ID
- NCT05790356
- Acronym / sponsor ID
- FeMiTRA / FeMiTRA01
- Keywords
- Arthritis, Rheumatoid, Rheumatoid Arthritis, clinical trial, fecal matter transplantation, fecal matter transplant, faecal, autoimmune
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled proof-of-concept study.
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbial Transplant | Experimental | Drug: Fecal Microbial transplantParticipants 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. |
| Placebo | Placebo comparator | Other: Placebo capsulesParticipants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial transplantAlso: FMT CapsulesFecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis. | Drug | Fecal Microbial Transplant |
| Placebo capsulesAlso: PlaceboThe placebo capsules will not contain FMT but will have the same appearance. | Other | Placebo |
Primary outcome
Change in Intestinal Permeability
Time frame: Baseline and 6 weeks
A blood sample will be collected for bacterial DNA analysis.
Change in Intestinal Permeability
Time frame: Baseline and 6 weeks
A urine sample will be collected to measure the lactulose to mannitol ratio.
Change in RA-associated autoantibodies
Time frame: Baseline, 6 weeks and 12 weeks
A blood sample will be collected to measure RA-associated autoantibodies.
Adverse Events
Time frame: Baseline
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Adverse Events
Time frame: FMT treatment visit
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Adverse Events
Time frame: 6 weeks post-treatment
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Adverse Events
Time frame: 12 weeks post-treatment
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
2 secondary outcomes
Change in Fecal Microbial Composition
Time frame: Baseline, 6 weeks and 12 weeks
Change in C-Reactive Protein
Time frame: Baseline, 6 weeks and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 21921096Bykerk 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.
- Background: PubMed 26301589Barnabe C, Sun Y, Boire G, Hitchon CA, Haraoui B, Thorne JC, Tin D, van der Heijde D, Curtis JR, Jamal S, Pope JE, Keystone EC, Bartlett S, Bykerk VP; CATCH Investigators. Heterogeneous Disease Trajectories Explain Variable Radiographic, Function and Quality of Life Outcomes in the Canadian Early Arthritis Cohort (CATCH). PLoS One. 2015 Aug 24;10(8):e0135327. doi: 10.1371/journal.pone.0135327. eCollection 2015.
- Background: PubMed 22707613Bombardier C, Hazlewood GS, Akhavan P, Schieir O, Dooley A, Haraoui B, Khraishi M, Leclercq SA, Legare J, Mosher DP, Pencharz J, Pope JE, Thomson J, Thorne C, Zummer M, Gardam MA, Askling J, Bykerk V; Canadian Rheumatology Association. Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety. J Rheumatol. 2012 Aug;39(8):1583-602. doi: 10.3899/jrheum.120165. Epub 2012 Jun 15.
- Background: PubMed 30886969Munro S, Spooner L, Milbers K, Hudson M, Koehn C, Harrison M. Perspectives of patients, first-degree relatives and rheumatologists on preventive treatments for rheumatoid arthritis: a qualitative analysis. BMC Rheumatol. 2018 Jul 5;2:18. doi: 10.1186/s41927-018-0026-7. eCollection 2018.
- Background: PubMed 30821924Loyola-Sanchez A, Hazlewood G, Crowshoe L, Linkert T, Hull PM, Marshall D, Barnabe C. Qualitative Study of Treatment Preferences for Rheumatoid Arthritis and Pharmacotherapy Acceptance: Indigenous Patient Perspectives. Arthritis Care Res (Hoboken). 2020 Apr;72(4):544-552. doi: 10.1002/acr.23869.
- Background: PubMed 33633444Taylor PC, Ancuta C, Nagy O, de la Vega MC, Gordeev A, Jankova R, Kalyoncu U, Lagunes-Galindo I, Morovic-Vergles J, de Souza MPGUES, Rojkovich B, Sidiropoulos P, Kawakami A. Treatment Satisfaction, Patient Preferences, and the Impact of Suboptimal Disease Control in a Large International Rheumatoid Arthritis Cohort: SENSE Study. Patient Prefer Adherence. 2021 Feb 17;15:359-373. doi: 10.2147/PPA.S289692. eCollection 2021.
- Background: PubMed 32602263Deane KD, Holers VM. Rheumatoid Arthritis Pathogenesis, Prediction, and Prevention: An Emerging Paradigm Shift. Arthritis Rheumatol. 2021 Feb;73(2):181-193. doi: 10.1002/art.41417. Epub 2020 Dec 8.
- Background: PubMed 32060812Wilson AS, Koller KR, Ramaboli MC, Nesengani LT, Ocvirk S, Chen C, Flanagan CA, Sapp FR, Merritt ZT, Bhatti F, Thomas TK, O'Keefe SJD. Diet and the Human Gut Microbiome: An International Review. Dig Dis Sci. 2020 Mar;65(3):723-740. doi: 10.1007/s10620-020-06112-w.
- Background: PubMed 33674813Zaiss MM, Joyce Wu HJ, Mauro D, Schett G, Ciccia F. The gut-joint axis in rheumatoid arthritis. Nat Rev Rheumatol. 2021 Apr;17(4):224-237. doi: 10.1038/s41584-021-00585-3. Epub 2021 Mar 5.
- Background: PubMed 24192039Scher JU, Sczesnak A, Longman RS, Segata N, Ubeda C, Bielski C, Rostron T, Cerundolo V, Pamer EG, Abramson SB, Huttenhower C, Littman DR. Expansion of intestinal Prevotella copri correlates with enhanced susceptibility to arthritis. Elife. 2013 Nov 5;2:e01202. doi: 10.7554/eLife.01202.
- Background: PubMed 28914373Mohammed AT, Khattab M, Ahmed AM, Turk T, Sakr N, M Khalil A, Abdelhalim M, Sawaf B, Hirayama K, Huy NT. The therapeutic effect of probiotics on rheumatoid arthritis: a systematic review and meta-analysis of randomized control trials. Clin Rheumatol. 2017 Dec;36(12):2697-2707. doi: 10.1007/s10067-017-3814-3. Epub 2017 Sep 15.
- Background: PubMed 29879241Meyers S, Shih J, Neher JO, Safranek S. Clinical Inquiries: How effective and safe is fecal microbial transplant in preventing C difficile recurrence? J Fam Pract. 2018 Jun;67(6):386-388.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Barra, MD, MPH principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial transplant in people with Arthritis and Arthritis, Rheumatoid, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lillian Barra, MD, MPH (519-646-6100 ext. 65986, Lillian.Barra@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intestinal Permeability (time frame: Baseline and 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790356, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.