Probiotics in primary sclerosing cholangitis: a randomized placebo-controlled crossover pilot study.
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.
Vleggaar
Frank P
FP
Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands. f.vleggaa@umcutrecht.nl
Monkelbaan
Jan F
JF
van Erpecum
Karel J
KJ
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
D015415:Biomarkers; D000469:Alkaline Phosphatase; D001663:Bilirubin