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VSL#3 reduced hospitalizations, liver disease severity in cirrhotic patients

Hospitalizations and severity of liver disease decreased among patients with cirrhosis assigned the probiotic VSL#3 compared with those receiving placebo in a clinical trial.

In a double blind, controlled trial, researchers randomly assigned 130 patients with cirrhosis to the probiotic VSL#3 (CD Pharma India; n=66) or placebo (n=64) daily for 6 months. All patients had recovered from a bout of hepatic encephalopathy that occurred 1 month before study commencement.

Researchers said 34.8% of patients in the VSL#3 group experienced a breakthrough episode of overt HE (HR=0.65; 95% CI, 0.38-1.11) compared with 51.6% of placebo patients. Breakthrough HE was considered low grade in 43.5% of probiotic patients; if needed, outpatient care was utilized. By comparison 87.9% of placebo patients had high-grade HE requiring hospitalization (P=.01).

Approximately 24% of patients assigned VSL#3 were hospitalized (HR=0.52; 95% CI, 0.28-0.95) compared with 45% of placebo patients. Hospitalization due to HE was more common among the placebo cohort (42.2% vs. 19.7%; P=.02). Neither group reported any treatment-related adverse events; 30 patients died, however, during the study. Mortality was primarily attributed to end-stage liver failure with complications. At 24 weeks MELD and Child-Turcotte-Pugh scores improved among the probiotic patients, but not the placebo patients.

“[VSL#3] when used for secondary prophylaxis of HE, results in significant reductions in hospitalization over a 6-month period; reduction in severity of breakthrough episodes of encephalopathy with concomitant improvement in [health-related quality of life] parameters; [psychometric hepatic encephalopathy score]; reduction in inflammatory markers; and improvements in liver function and biochemical measures of systemic hemodynamics without any significant adverse effects,” the researchers concluded.

Disclosure: The researchers report no relevant financial disclosures.