title: Probiotic VSL#3 reduces liver disease severity and hospitalization in patients with cirrhosis: a randomized, controlled trial.
abstract: OBJECTIVE
  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 × 10(11) 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.
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India. Electronic address: rkpsdhiman@hotmail.com.
authors.forename: Radha K
authors.initials: RK
authors.lastname: Dhiman
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Baldev
authors.initials: B
authors.lastname: Rana
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Swastik
authors.initials: S
authors.lastname: Agrawal
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Garg
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Madhu
authors.initials: M
authors.lastname: Chopra
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Kiran K
authors.initials: KK
authors.lastname: Thumburu
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Amit
authors.initials: A
authors.lastname: Khattri
authors.affiliation: Department of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Samir
authors.initials: S
authors.lastname: Malhotra
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Ajay
authors.initials: A
authors.lastname: Duseja
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: Yogesh K
authors.initials: YK
authors.lastname: Chawla
mesh_terms: D015415:Biomarkers / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006501:Hepatic Encephalopathy / Q000178:diet therapy* / Q000382:microbiology / Q000401:mortality; D017052:Hospital Mortality; D006760:Hospitalization; D006801:Humans; D008103:Liver Cirrhosis / Q000178:diet therapy* / Q000382:microbiology / Q000401:mortality; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012008:Recurrence; D012720:Severity of Illness Index; D062606:Tertiary Care Centers; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers
keywords: CTP; Gut Microbiome; Inflammation; MELD