University of Nebraska Medical Center

Fecal Microbiota (Rebyota)

The Pharmacy and Therapeutics Committee approved the addition of Fecal Microbiota (Rebyota) to the formulary in March 2023 with use restricted to outpatient clinics and the infusion center only for Clostridioides difficile infection prophylaxis.  


The primary efficacy analysis of the Phase 3 double blind, RCT (Randomized Controlled Trial), placebo-controlled study 2017-01 (PUNCH CD3) met the second pre-specified statistical success threshold 0.9750 but did not meet the more stringent 0.9993 first specified success threshold.  

Prior to performing the analysis, the FDA (Food and Drug Administration) concluded that a posterior finding equivalent to meeting the first specified success threshold would be sufficient to demonstrate substantial evidence of effectiveness.  

After the primary efficacy analysis only met the second specified success criteria, FDA considered whether the data from the study, as well as the data from the supportive clinical trials would be sufficient to demonstrate substantial evidence of effectiveness. Most FDA committee members thought the clinical data were adequate to support effectiveness of the product.  The review team concluded that the data submitted demonstrates substantial evidence of effectiveness for the prevention of recurrent CDI (Clostridioides Difficile Infection) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. 


Rebyota is manufactured from human fecal matter donated by qualified individuals. The donors and donated stool are screened for transmissible pathogens; however, there may still be a risk of transmitting infectious agents. Additionally, it is possible that Rebyota may contain food allergens; the potential for adverse reactions due to food allergens is unknown. 


Rebyota is the first fecal transplant therapy for recurrent CDI approved by FDA.  This therapy is approved for prophylaxis and is not considered for treatment of CDI. 

Click for additional information about Rebyota