• Antibiotics treat the acute infection, however they do not restore the beneficial microbes3

  • As long as an individual remains in a dysbiotic state they are at an increased risk of C. diff

  • Treatments that can restore the microbiome will help promote resistance to future C. diff2

Microbiome restoration treatment does not replace antibiotics4

After the acute infection has been treated, the patient can then be given treatment to restore their microbiome5,6

Fecal microbiota transplantation (FMT), which has historically been used for microbiome restoration, has limitations7

FMT has been shown to be efficacious in treating recurrent C. diff and reestablishing gut biodiversity.8 However, several challenges may exist in the preparation and provision of FMT including:

Treatment

  • Stool donor identification, recruitment and retention9

  • Heterogeneity in sample testing10

  • Preparation techniques can be laborious and lack automation9

  • Lack of infrastructure for, and standardization of, preparation/manufacture5,9,10

  • Multiple safety alerts issued (FDA, Health Canada) regarding the potential risk of serious or life-threatening infections following FMT9,11

Clinical Studies

  • Data is derived from different study types such as retrospective case series, randomized controlled clinical trials and open-label studies resulting in considerable variability

  • Treatment success, defined as clinical cure of C. diff, assessed in a meta-analysis of 13 clinical trials of single dose FMT demonstrated a range in outcomes based on study type:12

67.7% in randomized controlled trials to 82.7% in open-label studies12

Probiotics do not restore the microbiome nor address dysbiosis

  • They are designed to help maintain a healthy gut microbiome13

  • Clinical guidelines recommend against probiotics for the prevention of recurrent C. diff14

  • They may hinder normal colon recolonization following antibiotic treatment15

A safe, regulated, and reliable option for restoring the microbiome is vitally needed to reduce the burden of C. difficile  infection (C. diff) and recurrence.1,2

C. diff = C. difficile infection

FDA = U.S. Food and Drug Administration

Click back to learn how

Recurrent C. diff Infection

can result from dysbiosis and the use of antibiotics

Click forward to learn about the

Patient & Healthcare Impact

of C. diff

References

  1. Langdon A, Schwartz DJ, Bulow C, et al. Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostrididoides difficile infection from the open-label PUNCH CD Study. Genome Med. 2021;13:28.

  2. Seekatz AM, Safdar N, Khanna S. The role of the gut microbiome in colonization resistance and recurrent Clostridioides difficile infection. Therap Adv Gastroenterol. 2022;15:1-18.

  3. Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.

  4. Normington C, Chilton CH, Buckley AM. Clostridioides difficile infection; new treatments and future perspectives. Curr Opin Gastroenterol. 2024;40(1):7-13.

  5. Khanna S. Microbiota restoration for recurrent Clostridioides difficile: Getting one step closer every day! J Intern Med. 2021;290(2):294-309.

  6. Schwartz DJ, Langdon AE, Dantas G. Understanding the impact of antibiotic perturbation on the human microbiome. Genome Med. 2020;12(82):1-12.

  7. Ashraf MF, Tageldin O, Nassar Y, et al. Fecal Microbiota Transplantation in Patients With Recurrent Clostridium difficile infection: A Four-Year Single Center Retrospective Review. Gastroenterology Res. 2021;14(4):237-243.

  8. Van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013;368(5):407-415.

  9. Quay T, Walter M. Fecal Microbiota Therapy in Canada: An Environmental Scan. CADTH. 2020;(95):1-36.

  10. Gawey BJ, Khanna S. Clostridioides difficile Infection: Landscape and Microbiome Therapeutics. Gastroenterol Hepatol (N  Y). 2023;19(6):319-328.

  11. U.S. Food and Drug Administration website. Fecal Microbiota for Transplantation: Safety Alert–Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms. Accessed March 12, 2022, at https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-risk-serious-adverse-events-likely-due-transmission.

  12. Tariq R, Pardi DS, Bartlett MG, et al. Low cure rates in controlled trials of fecal microbiota transplantation for recurrent Clostridium difficile infection: a systematic review and meta-analysis. Clin Infect Dis. 2019;68(8):1351-1358.

  13. Cordaillat-Simmons M, Rouanet A, Pot B. Live biotherapeutic products: the importance of a defined regulatory framework. Exp Mol Med. 2020;52(9):1397-1406.

  14. Kelly CR, Fischer M, Allegretti JR, et al. ACG Clinical Guidelines: prevention, diagnosis, and treatment of Clostridioides difficile infections. Am J Gastroenterol. 2021;116(6):1124-1147.

  15. Suez J, Zmora N, Ziblerman-Schapira G, et al. Post-antibiotic gut mucosal microbiome reconstitution is impaired by probiotics and improved by autologous FMT. Cell. 2018;174(6):1406-1423.e16.

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CA-REB-2300004 Date of preparation March 2024