Fecal Microbial Transplantation for Rheumatoid Arthritis 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.

Timeline

Start

2023-08-01

Primary completion

2025-08-01

Completion

2026-04-01

Publications

• Background 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.
• Background Barnabe 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 Bombardier 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 Munro 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 Loyola-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 Taylor 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 Deane 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 Wilson 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 Zaiss 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 Scher 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 Mohammed 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 Meyers 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.
• Background Claytor 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.
• Background Chapman 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.
• Background Sun 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.
• Background Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, Madsen K, Mason A, Wong GK, Jovel J, Patterson J, Louie T. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077.
• Background Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.
• Background Craven LJ, Nair Parvathy S, Tat-Ko J, Burton JP, Silverman MS. Extended Screening Costs Associated With Selecting Donors for Fecal Microbiota Transplantation for Treatment of Metabolic Syndrome-Associated Diseases. Open Forum Infect Dis. 2017 Nov 6;4(4):ofx243. doi: 10.1093/ofid/ofx243. eCollection 2017 Fall.
• Background Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.
• Background Vehreschild MJ, Cornely OA. Fecal Microbiota Transfer 2.0. J Infect Dis. 2016 Jul 15;214(2):169-70. doi: 10.1093/infdis/jiv768. Epub 2016 Feb 8. No abstract available.
• Background Neill J, Belan I, Ried K. Effectiveness of non-pharmacological interventions for fatigue in adults with multiple sclerosis, rheumatoid arthritis, or systemic lupus erythematosus: a systematic review. J Adv Nurs. 2006 Dec;56(6):617-35. doi: 10.1111/j.1365-2648.2006.04054.x.
• Background Gwinnutt JM, Wieczorek M, Balanescu A, Bischoff-Ferrari HA, Boonen A, Cavalli G, de Souza S, de Thurah A, Dorner TE, Moe RH, Putrik P, Rodriguez-Carrio J, Silva-Fernandez L, Stamm T, Walker-Bone K, Welling J, Zlatkovic-Svenda MI, Guillemin F, Verstappen SMM. 2021 EULAR recommendations regarding lifestyle behaviours and work participation to prevent progression of rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2023 Jan;82(1):48-56. doi: 10.1136/annrheumdis-2021-222020. Epub 2022 Mar 8.
• Background Skoldstam L, Hagfors L, Johansson G. An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. Ann Rheum Dis. 2003 Mar;62(3):208-14. doi: 10.1136/ard.62.3.208.
• Background Holers VM, Demoruelle MK, Kuhn KA, Buckner JH, Robinson WH, Okamoto Y, Norris JM, Deane KD. Rheumatoid arthritis and the mucosal origins hypothesis: protection turns to destruction. Nat Rev Rheumatol. 2018 Sep;14(9):542-557. doi: 10.1038/s41584-018-0070-0.
• Background Svard A, Roos Ljungberg K, Brink M, Martinsson K, Sjowall C, Rantapaa Dahlqvist S, Kastbom A. Secretory antibodies to citrullinated peptides in plasma and saliva from rheumatoid arthritis patients and their unaffected first-degree relatives. Clin Exp Immunol. 2020 Feb;199(2):143-149. doi: 10.1111/cei.13381. Epub 2019 Oct 22.
• Background Kay J, Upchurch KS. ACR/EULAR 2010 rheumatoid arthritis classification criteria. Rheumatology (Oxford). 2012 Dec;51 Suppl 6:vi5-9. doi: 10.1093/rheumatology/kes279.
• Background Craven L, Rahman A, Nair Parvathy S, Beaton M, Silverman J, Qumosani K, Hramiak I, Hegele R, Joy T, Meddings J, Urquhart B, Harvie R, McKenzie C, Summers K, Reid G, Burton JP, Silverman M. Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial. Am J Gastroenterol. 2020 Jul;115(7):1055-1065. doi: 10.14309/ajg.0000000000000661.
• Background Al KF, Bisanz JE, Gloor GB, Reid G, Burton JP. Evaluation of sampling and storage procedures on preserving the community structure of stool microbiota: A simple at-home toilet-paper collection method. J Microbiol Methods. 2018 Jan;144:117-121. doi: 10.1016/j.mimet.2017.11.014. Epub 2017 Nov 16.
• Background Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
• Background Aletaha D, Ward MM, Machold KP, Nell VP, Stamm T, Smolen JS. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Arthritis Rheum. 2005 Sep;52(9):2625-36. doi: 10.1002/art.21235.
• Background Daisley BA, Chanyi RM, Abdur-Rashid K, Al KF, Gibbons S, Chmiel JA, Wilcox H, Reid G, Anderson A, Dewar M, Nair SM, Chin J, Burton JP. Abiraterone acetate preferentially enriches for the gut commensal Akkermansia muciniphila in castrate-resistant prostate cancer patients. Nat Commun. 2020 Sep 24;11(1):4822. doi: 10.1038/s41467-020-18649-5.

Drugs

Indications