title: VSL#3 ® probiotic therapy does not reduce portal pressures in patients with decompensated cirrhosis.
abstract: OBJECTIVE
  In patients with decompensated cirrhosis, bacterial translocation can contribute to splanchnic vasodilatation, decreased effective circulating volume, and portal hypertension. The primary objective of this randomized, double blind placebo controlled trial was to evaluate the effect of the probiotic VSL#3(®) on the hepatic venous pressure gradient (HVPG).
  
  
  METHODS
  Seventeen patients with decompensated cirrhosis and an HVPG of ≥ 10 mmHg were randomized to receive 2 months of VSL#3(®) or an identical placebo. HVPG, endotoxin, interleukin (IL)-6, IL-8, IL-10, renin, aldosterone, nitric oxide and stool microbiota were measured at baseline and study end.
  
  
  RESULTS
  Two of the 17 patients were taken off the trial before completion (one for alcohol abuse and the second for SBP - both in placebo arm). Data were analysed on the remaining 15 patients. The median model for end-stage liver disease score was 12, and 80% of patients had Child Pugh B disease. The treatment arm had a greater decrease in HVPG from baseline to study end than the placebo arm (median change from baseline -11.6% vs +2.8%), although this reduction was not statistically significant in either group. There was a significant reduction in the plasma aldosterone level in the VSL#3(®) group, but no significant changes in the other measured parameters, including the stool microflora analysis.
  
  
  CONCLUSIONS
  Within the limitations of our sample size, VSL#3(®) therapy does not appear to have a significant impact on portal pressure reduction in patients with decompensated cirrhosis.
authors: Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
authors: Saumya
authors: S
authors: Jayakumar
authors: Michelle
authors: M
authors: Carbonneau
authors: Naomi
authors: N
authors: Hotte
authors: A Dean
authors: AD
authors: Befus
authors: Chris
authors: C
authors: St Laurent
authors: Richard
authors: R
authors: Owen
authors: Mairin
authors: M
authors: McCarthy
authors: Karen
authors: K
authors: Madsen
authors: Robert J
authors: RJ
authors: Bailey
authors: Mang
authors: M
authors: Ma
authors: Vince
authors: V
authors: Bain
authors: Kevin
authors: K
authors: Rioux
authors: Puneeta
authors: P
authors: Tandon
mesh_terms: D000450:Aldosterone / Q000097:blood; D018925:Chemokines / Q000097:blood; D017931:DNA Primers / Q000235:genetics; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012150:Polymorphism, Restriction Fragment Length; D017082:Portal Pressure / Q000187:drug effects* / Q000502:physiology; D019936:Probiotics / Q000494:pharmacology* / Q000627:therapeutic use*; D011863:Radioimmunoassay; D012083:Renin / Q000097:blood; D018709:Statistics, Nonparametric
chemical_list: D018925:Chemokines; D017931:DNA Primers; D000450:Aldosterone; D012083:Renin
keywords: double blind; hepatic venous portal gradient; placebo controlled; portal hypertension; randomized