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fecal transplantation

Indication: - recurrent* C difficile colitis - cost effective - may be treatment of choice [4] - *safe & effective in immunocompromised patients - reduces risk of C difficile colitis recurrence [11] - severe or fulminant C difficile colitis [20] - active ulcerative colitis [9] not recommended [20] - irritable bowel syndrome, diarrhea predominant (IBS-D) [12] (not recommended) [20] * little evidence on efficacy for patients with refractory C difficile colitis or a first episode [7] * effective for patients after a first or second episode of C difficile colitis [19] * recommended only second recurrence (third episode) of C difficile colitis [20] Contraindications: - severely immunocompromised patients [20] - inflammatory bowel disease [20] - irritable bowel syndrome [20] Procedure: - donors should be tested for extended spectrum beta-lactamase producing E coli [15] - commercial product: fecal microbiota (Rebyota) - bowel preparation with polyethylene glycol - performed at colonoscopy by infusing fresh donor feces into cecum [2] or duodenum [3] - oral administation of non-toxigenic Clostridium difficile spores (3 doses)* - fecal microbiota transplantation via oral capsules not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks [13] - enema of fecal microbiota weekly for 6 weeks for ulcerative colitis [9] - frozen stool samples may be as effective as fresh samples for fecal transplantation [10] * non-toxigenic C difficile strains lack the genes for toxin production &, thus, may colonize the gut without causing colitis [8] Clinical significance: - resolution of symptoms without recurrence within 90 days (91%) [2]; 90% resolution within 30 days [17] - 81% [3]; 90% with a 2nd fecal transplantation from a different donor [3] - resolution of symptoms after an additional course of vancomycin with or without repeat transplant (98%) [2] - oral non-toxigenic Clostridium difficile spores reduces recurrence of C-difficile colitis (11% vs 30%) [8] * overall efficacy is 85%, but evidence is weak [7] Complications: - 4 of 77 patients developed new medical conditions, including peripheral neuropathy, Sjogren syndrome, rheumatoid arthritis, & idiopathic thrombocytopenic purpura (not definitively linked to fecal transplantation) [2] - transmission of pathogenic organisms [16] - fecal transplantation of extended spectrum beta-lactamase producing E coli may be fatal in immunocompromised patient [14.15] Specimen: - donor stool may be frozen [10] Notes: - first human stool bank - fecal microbiota (Rebyota)

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fecal microbiota (Rebyota)

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References

  1. Mattila E et al. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology 2012 Mar; 142:490. PMID: 22155369
  2. Brandt LJ et al. Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. Am J Gastroenterol 2012 Jul; 107:1079. PMID: 22450732
  3. van Nood E et al Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. New Engl J Med. January 16, 2013 PMID: 23323867 http://www.nejm.org/doi/full/10.1056/NEJMoa1205037 - Kelly CP Fecal Microbiota Transplantation - An Old Therapy Comes of Age. New Engl J Med. January 16, 2013 PMID: 23323865 http://www.nejm.org/doi/full/10.1056/NEJMe1214816
  4. Konijeti GG et al. Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: A decision analysis. Clin Infect Dis 2014 Mar 31; PMID: 24692533 - Youngster I et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: A randomized, open-label, controlled pilot study. Clin Infect Dis 2014 Apr 23; PMID: 24762631
  5. Burke KE, Lamont JT. Fecal transplantation for recurrent Clostridium difficile infection in older adults: a review. J Am Geriatr Soc. 2013;61:1394-1398. PMID: 23869970
  6. Kelly CR et al. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol 2014 Jul; 109:1065 PMID: 24890442
  7. Drekonja D et al Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review Ann Intern Med. 2015;162(9):630-638 PMID: 25938992 http://annals.org/article.aspx?articleid=2288521
  8. Gerding DN et al Administration of Spores of Nontoxigenic Clostridium difficile Strain M3 for Prevention of Recurrent C difficile Infection. A Randomized Clinical Trial. JAMA. 2015;313(17):1719-1727 PMID: 25942722 http://jama.jamanetwork.com/article.aspx?articleid=2281703
  9. Moayyedi P et al. Fecal microbiota transplantation induces remission in patients with active ulcerative colitis in a randomized controlled trial. Gastroenterology 2015 Jul; 149:102 PMID: 25857665
  10. Lee CH, Steiner T, Petrof EO et al Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection. A Randomized Clinical Trial. JAMA. 2016;315(2):142-149. http://jama.jamanetwork.com/article.aspx?articleid=2481003
  11. Kelly CR, Khoruts A, Staley C et al Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial. Ann Intern Med. Published online 23 August 2016 PMID: 27547925 http://annals.org/article.aspx?articleid=2545886 - Hohmann EL Are Microbial Politics Local? PMID: 27548329 http://annals.org/article.aspx?articleid=2545957
  12. Johnsen PH, Hilpusch F, Cavanagh JP et al Faecal microbiota transplantation versus placebo for moderate- to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterology and Hepatology Oct 31, 2017 PMID: 29100842 http://thelancet.com/journals/langas/article/PIIS2468-1253(17)30338-2/fulltext - Ford AC Stool as a treatment for IBS: more questions than answers? Lancet Gastroenterology and Hepatology Oct 31, 2017 PMID: 29100844 http://thelancet.com/journals/langas/article/PIIS2468-1253(17)30337-0/fulltext
  13. Kao D, Roach B, Silva M et al Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection. A Randomized Clinical Trial. JAMA. 2017;318(20):1985-1993 PMID: 29183074 https://jamanetwork.com/journals/jama/article-abstract/2664458 - Rao K, MD, Young VB, MD, Malani PN. Capsules for Fecal Microbiota Transplantation in Recurrent Clostridium difficile Infection.The New Way Forward or a Tough Pill to Swallow? JAMA. 2017;318(20):1979-1980 PMID: 29183052 https://jamanetwork.com/journals/jama/article-abstract/2664435
  14. FDA Safety Alert. June 13, 2019 Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi- Drug Resistant Organisms. https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due - FDA SafetyCommunication. June 13, 2019 Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse
  15. DeFilipp Z, Bloom PP, Torres Soto M Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. N Engl J Med. Oct 30, 2019 PMID: 31665575 https://www.nejm.org/doi/full/10.1056/NEJMoa1910437 - Kassam Z, Dubois N, Ramakrishna B et al Donor Screening for Fecal Microbiota Transplantation. N Engl J Med. Oct 30, 2019 PMID: 31665572 https://www.nejm.org/doi/full/10.1056/NEJMc1913670 - Blaser MJ Fecal Microbiota Transplantation for Dysbiosis - Predictable Risks. N Engl J Med. Oct 30, 2019 PMID: 31665573 https://www.nejm.org/doi/full/10.1056/NEJMe1913807
  16. FDA Safety Alert. March 12, 2020 Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms. https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-risk-serious-adverse-events-likely-due-transmission
  17. Kelly CR, Yen EF, Grinspan AM et al Fecal Microbiota Transplant is Highly Effective in Real-World Practice: Initial Results from the FMT National Registry. Gastroenterology, Oct 1, 2020 PMID: 33011173 https://www.gastrojournal.org/article/S0016-5085(20)35221-5/fulltext
  18. FDA Safety Alert. August 22, 2022 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections-0
  19. Baunwall SMD et al. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): A randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol 2022 Dec; 7:1083. PMID: 36152636 https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00276-X/fulltext - Allegretti JR. Should faecal microbiota transplantation be used earlier in the treatment framework? Lancet Gastroenterol Hepatol 2022 Dec; 7:1062. PMID: 36152634 https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00301-6/fulltext
  20. Peery AF et al. AGA clinical practice guideline on fecal microbiota-based therapies for select gastrointestinal diseases. Gastroenterology 2024 Mar; 166:409. PMID: 38395525 https://www.gastrojournal.org/article/S0016-5085(24)00041-6/fulltext
  21. OpenBiome: Clinician FAQs http://www.openbiome.org/clinical-faqs/