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About Recurrent C. diff Infection

Clostridioides difficile (C. diff) can come back. Learn about recurrent C. diff, 
how your gut microbiome impacts your health, and get tips to stop the spread.

REBYOTA Patient Portrayal

C. diff infection and its recurrence

C. diff is a bacteria that can cause an infection in the gut. Symptoms can range from diarrhea to life-threatening damage to the colon.1 Sometimes, a C. diff infection can come back more than once. This is called a recurrence.1,2 If left untreated, it too can cause severe illness, and even death.1

35% of people icon

Up to 35% of people who get 
a C. diff infection may have
 a recurrence3,4

65% of people icon

Up to 65% of people who experience a recurrence may have a second or third or more5,6

Antibiotics treat C. diff infection but can also be the leading cause of C. diff recurrence1,7

Doctor icon

Only your doctor can diagnose 
a recurrence of C. diff infection. If you 
have been taking antibiotics and 
have any of these symptoms below, 
this may indicate a recurrence.

Symptoms of recurrent C. diff infection20

  • Diarrhea
  • Fever
  • Stomach tenderness or pain
  • Loss of appetite
  • Nausea

If you experience a recurrence...

A recurrence can be mentally demanding and physically challenging. If you experience any symptoms of C. diff infection, please start a conversation with your doctor about recurrence prevention.

If left untreated, a C. diff infection recurrence can lead to:

  • Continued abdominal pain and diarrhea2
  • Extended stays in the hospital21
  • Sepsis22
  • Surgery to remove part of the colon (colectomy)22
  • Death3
Flowers on a vine Flowers on a vine

Think you have recurrent C. diff infection?
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About REBYOTA

Learn how one dose of REBYOTA can keep C. diff from coming back.

About REBYOTA

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Learn how REBYOTA can be administered at your doctor’s office or in your home.

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References

  1. Bien J, Palagani V, Bozko P. The intestinal microbiota dysbiosis and Clostridium difficile infection: is there a relationship with inflammatory bowel disease? Therap Adv Gastroenterol. 2013;6(1):53-68.
  2. Antharam VC, Li EC, Ishmael A, et al. Intestinal dysbiosis and depletion of butyrogenic bacteria in Clostridium difficile infection and nosocomial diarrhea. J Clin Microbiol. 2013;51(9):2884-2892.
  3. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
  4. Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(suppl 2):S154-S161.
  5. Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21-27.
  6. Smits WK, Lyras D, Lacy DB, Wilcox MH, Kuijper EJ. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020.
  7. McDonald LC, Gerding DN, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1-e48.
  8. Gilbert JA, Blaser MJ, Caporaso JG, Jansson JK, Lynch SV, Knight R. Current understanding of the human microbiome. Nat Med. 2018;24(4):392-400.
  9. Thursby E, Juge N. Introduction to the human gut microbiota. Biochem J. 2017;474(11):1823-1836.
  10. Wexler AG, Goodman AL. An insider’s perspective: Bacteroides as a window into the microbiome. Nat Microbiol. 2017;2:17026.
  11. Li X, Kang Y, Huang Y, et al. A strain of Bacteroides thetaiotaomicron attenuates colonization of Clostridioides difficile and affects intestinal microbiota and bile acids profile in a mouse model. Biomed Pharmacother. 2021;137:111290.
  12. Paust S, Lu L, McCarty N, Cantor H. Engagement of B7 on effector T cells by regulatory T cells prevents autoimmune disease. Proc Natl Acad Sci U S A. 2004;101(28):10398-10403.
  13. El Aidy S, van Baarlen P, Derrien M, et al. Temporal and spatial interplay of microbiota and intestinal mucosa drive establishment of immune homeostasis in conventionalized mice. Mucosal Immunol. 2012;5(5):567-579.
  14. Lawley TD, Walker AW. Intestinal colonization resistance. Immunology. 2013;138(1):1-11.
  15. Sokol H, Pigneur B, Watterlot L, et al. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008;105(43):16731-16736.
  16. Willing BP, Dicksved J, Halfvarson J, et al. A pyrosequencing study in twins shows that gastrointestinal microbial profiles vary with inflammatory bowel disease phenotypes. Gastroenterology. 2010;139(6):1844-1854.e1.
  17. Machiels K, Joossens M, Sabino J, et al. A decrease of the butyrate-producing species Roseburia hominis and Faecalibacterium prausnitzii defines dysbiosis in patients with ulcerative colitis. Gut. 2014;63(8):1275-1283.
  18. 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.
  19. 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.
  20. Centers for Disease Control and Prevention website. What is C. diff? https://www.cdc.gov/cdiff/what-is.html. Accessed March 15, 2024.
  21. Nelson WW, Scott TA, Boules M, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis.  J Manag Care Spec Pharm. 2021;27(7):828-838.
  22. Feuerstadt P, Boules M, Stong L, et al. Clinical complications in patients with primary and recurrent Clostridioides difficile infection: a real-world data analysis. SAGE Open Med. 2021;9:2050312120986733.

Please see Important Safety Information and full Prescribing Information

INDICATION

REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
Limitation of Use
REBYOTA is not indicated for the treatment of C. diff infection.

Important Safety Information

  • You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components.
  • You should report to your doctor any infection you think you may have acquired after administration.
  • REBYOTA may contain food allergens.
  • Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
  • REBYOTA has not been studied in patients below 18 years of age.
  • Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.

Please click to see the full Prescribing Information.

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