Clostridioides difficile, formerly known as Clostridium difficile, is a bacterium that causes diarrhea and colitis, most frequently after a course of antibiotics. The Centers for Disease Control and Prevention estimates there are approximately 500,000 C. difficile infections yearly in the United States, and about one in six patients will experience a recurrent infection within two to eight weeks. After each recurrence, the patient becomes more likely to have another infection. The Food and Drug Administration has approved a live fecal microbiota product (Rebyota) for use after a course of antibiotics (usually vancomycin or fidaxomicin) to prevent recurrent episodes of C. difficile in adults. Rebyota is not approved for initial treatment of this infection.

Effectiveness of Rebyota was determined in two double-blind clinical trials of adults who had recurrent C. difficile and who had already received at least 10 consecutive days of standard antibiotic therapy with improvement of their symptoms. The rate of treatment success (no additional C. difficile diarrhea for eight weeks after treatment) was 70.6% with Rebyota and 57.5% with placebo using Bayesian analysis. According to The Medical Letter, the cost of one dose of Rebyota is $9,000. (See The Medical Letter [https://secure.medicalletter.org/TML-article-1671b] for more information; please note, parts of the website require a subscription.)

The most common adverse effects of Rebyota were abdominal pain, diarrhea, abdominal distention, flatulence, and nausea.

Rebyota must be thawed in a refrigerator prior to use. Nurses should rectally administer Rebyota 24 to 72 hours after the last dose of antibiotics for C. difficile. If possible, patients should empty their bladder and bowels before administration. Patients should be told not to take oral antibiotics for at least eight weeks after receiving Rebyota.

For more information on C. difficile, including prevention strategies and clinical guidelines, see http://www.cdc.gov/cdiff/clinicians/index.html. For complete prescribing information for Rebyota, go to http://www.fda.gov/media/163587/download.