Microbiome Disruption and C. diff Recurrence

Understand the gut microbiome and its role in recurrent C. diff infection.

The gut microbiome

Your gut is home to trillions of microbes—including both good and bad bacteria—that help maintain your overall health. This is called your gut microbiome. It can affect your immunity and nervous system and protect against infection.^1-3

When your gut microbiome is disrupted, bad bacteria like C. diff may take over and cause an infection. Sometimes, a C. diff infection can come back more than once. This is called a recurrence.^2,4

C. diff infection and recurrence

Antibiotics treat C. diff infection but do not treat the disruption of the gut microbiome. Microbiome disruption increases the risk of C. diff infection recurrence.^4,5

Up to 35% of people who get a C. diff infection may have a recurrence^6,7

Up to 65% of people who experience a recurrence may have a second or third or more^8,9

What could happen if C Diff Infection Comes Back

Learn About REBYOTA

REBYOTA is the first and only FDA approved microbiome-based treatment to prevent recurrent C. diff infection, after you’ve already taken antibiotics.¹²

If you’re ready to talk to a doctor, this customized discussion guide is a great way to prepare.

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References

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.
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.
Thursby E, Juge N. Introduction to the human gut microbiota. Biochem J. 2017;474(11):1823-1836.
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.
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.
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.
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.
Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21-27.
Smits WK, Lyras D, Lacy DB, Wilcox MH, Kuijper EJ. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020.
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.
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.
REBYOTA. Prescribing Information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022.

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