Probiotic VSL#3 Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized, Controlled Trial

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 147; no. 6; pp. 1327 - 1337.e3
• Main Authors: Dhiman, Radha K, Rana, Baldev, Agrawal, Swastik, Garg, Ashish, Chopra, Madhu, Thumburu, Kiran K, Khattri, Amit, Malhotra, Samir, Duseja, Ajay, Chawla, Yogesh K
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2014
• Subjects: Biomarkers - blood; CTP; Double-Blind Method; Female; Gastroenterology and Hepatology; Gut Microbiome; Hepatic Encephalopathy - diet therapy; Hepatic Encephalopathy - microbiology; Hepatic Encephalopathy - mortality; Hospital Mortality; Hospitalization; Humans; Inflammation; Liver Cirrhosis - diet therapy; Liver Cirrhosis - microbiology; Liver Cirrhosis - mortality; Male; MELD; Microbiota; Middle Aged; Probiotics - administration & dosage; Probiotics - adverse effects; Quality of Life; Recurrence; Severity of Illness Index; Tertiary Care Centers; Treatment Outcome; brain-type natriuretic peptide; Postgraduate Institute of Medical Education and Research; PHES; BNP; PGIMER; figure connection test; HR; Gut Microbiome; MHE; TNF; Pittsburgh Sleep Quality Index; FCT-A; systemic inflammatory response syndrome; hepatic encephalopathy; Child–Turcotte–Pugh; interleukin; SBP; Epworth Sleepiness Scale; minimal hepatic encephalopathy; model for end-stage liver disease; IL; ESS; CI; Inflammation; health-related quality of life; number connection test; Medical Outcomes Study Short-Form (36-item) Health Survey (version 2); SIRS; SF-36v2; MELD; tumor necrosis factor; psychometric hepatic encephalopathy score; hazard ratio; HRQOL; confidence interval; spontaneous bacterial peritonitis; HE; CTP; NCT; PSQI
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2014.08.031

Background & Aims Little is known about whether probiotics can affect outcomes of patients with cirrhosis and hepatic encephalopathy (HE). We assessed the efficacy of a probiotic preparation in preventing the recurrence of HE (primary outcome) and reducing the number of hospitalizations and severity of liver disease in patients with cirrhosis. Methods We performed a double-blind trial at a tertiary care hospital in India. Patients with cirrhosis who had recovered from an episode of HE during the previous month were assigned randomly (using computer-generated allocation) to groups given a probiotic preparation (VSL#3, 9 × 1011 bacteria; CD Pharma India Private Limited, New Delhi, India) (n = 66) or placebo (n = 64) daily for 6 months. Results There was a trend toward a reduction in the development of breakthrough HE among patients receiving the probiotic (34.8% in the probiotic group vs 51.6% in the placebo group; hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.38–1.11; P  = .12). Fewer patients in the probiotic group were hospitalized for HE (19.7% vs 42.2%, respectively; HR, 0.45; 95% CI, 0.23–0.87; P  = .02) or for complications of cirrhosis (24.2%) than in the placebo group (45.3%) (HR, 0.52; 95% CI, 0.28–0.95; P  = .034). Child–Turcotte–Pugh and model for end-stage liver disease scores improved significantly from baseline to 6 months in the probiotic group, but not in the placebo group. There were no adverse events related to VSL#3. Conclusions Over a 6-month period, daily intake of VSL#3 significantly reduced the risk of hospitalization for HE, as well as Child–Turcotte–Pugh and model for end-stage liver disease scores, in patients with cirrhosis. ClinicalTrials.gov number: NCT01110447.