Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis.

Abstract

Clostridium difficile infections (CDI) are a leading cause of antibiotic-associated diarrhea, and recurrent infections are common despite effective antibiotic treatments. Recurrent CDI causes a significant burden to the patient and healthcare system, which has led to efforts to find an effective treatment to prevent recurrent CDI. Recent studies have shown the efficacy and safety of orally and rectally administered microbiota treatment to prevent recurrent Clostridium difficile. This study systematically reviewed the data on the efficacy and safety of RBX2660 (REBYOTA®), the first rectally administered microbiota product to prevent recurrent Clostridium difficile infections approved by the United States Food and Drug Administration (FDA). Our analysis showed that RBX2660 (REBYOTA) effectively prevented recurrent CDI. Patients who received RBX2660 (REBYOTA) were significantly less likely to have recurrent Clostridium difficile than controls eight weeks after treatment. This effect is seen in both those who got one or two doses of RBX2660 (REBYOTA), although the FDA currently approves one dose.