title: Probiotics in primary sclerosing cholangitis: a randomized placebo-controlled crossover pilot study.
abstract: BACKGROUND
  Beneficial effects of probiotics have been reported in liver disease. Inflammatory bowel disease concurs in 90% of primary sclerosing cholangitis (PSC) patients, suggesting that substances originating from the inflamed gut may damage the biliary tree.
  
  
  OBJECTIVE
  To assess potential beneficial effects of probiotics on serum liver tests, pruritus and fatigue in PSC.
  
  
  METHODS
  Fourteen patients (13 male/one female, mean age 45 years), with concurrent inflammatory bowel disease were randomized to treatment with probiotics (Ecologic 641, containing four Lactobacillus and two Bifidobacillus strains; Winclove Bio Industries, Amsterdam, The Netherlands) or placebo during 3 months in a double-blind fashion. After a 1-month washout period, crossover was made.
  
  
  RESULTS
  No changes in pruritus, fatigue and stool frequency were noted during placebo or probiotics. No significant differences were observed between treatment with probiotics and placebo in bilirubin (at end of probiotic vs. placebo period: -13 vs. -15% change from baseline; P=0.89), alkaline phosphatase (-9 vs. -9%; P=0.99), gamma glutamyl transpeptidase (-11 vs. -5%; P=0.60), aspartate aminotransferase (-16 vs. -15%; P=0.99), alanine aminotransferase (-27 vs. -26%; P=0.97), prothrombin, albumin or bile salts.
  
  
  CONCLUSIONS
  Our data do not support beneficial effects of probiotics on symptoms, liver biochemistry or liver function in PSC.
authors.affiliation: Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands. f.vleggaa@umcutrecht.nl
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
authors.forename: Jan F
authors.initials: JF
authors.lastname: Monkelbaan
authors.forename: Karel J
authors.initials: KJ
authors.lastname: van Erpecum
mesh_terms: D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D001644:Bifidobacterium; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D015209:Cholangitis, Sclerosing / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D004812:Epidemiologic Methods; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008099:Liver / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D000469:Alkaline Phosphatase; D001663:Bilirubin