Fecal Microbiota Transplant for Recurrent Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a common complication of cirrhosis. Standard-of-care (SOC) treatments, including lactulose and rifaximin, are sometimes ineffective. It has been suggested that HE is due to microbial dysbiosis, and studies show that patients with HE have a relative dearth of beneficial short-chain fatty acid–producing biota and enrichment of pathogenic Enterobacteriaceae. In the current open-label randomized study, researchers evaluated the use of fecal microbiota transplantation (FMT) from a single rationally identified (i.e., using microbiome data) stool donor in patients with cirrhosis and recurrent HE.

Twenty patients were randomized in a 1:1 ratio to SOC alone or SOC plus 5 days of pretreatment broad-spectrum antibiotics followed by a single FMT enema from a single donor. Patients were followed for 5 months. The primary endpoint was safety based on FMT-related serious adverse events. A secondary endpoint was improvement in cognition. At baseline, both groups were similar in terms of demographics, past HE history, and liver function.

The FMT group had a significantly lower rate of serious adverse events compared with the SOC-only group (20% vs. 80%), and none were FMT related. Furthermore, during the follow-up period, none of the FMT patients developed HE, compared with five (50%) in the SOC-only group (P=0.03). There was improvement in cognition from baseline in the FMT group but not the SOC-only group.