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A Double-Blind, Randomized Placebo-Controlled Trial of Probiotic Lactobacillus casei Shirota in Stable Cirrhotic Patients.

  • 2020-06-02
  • Nutrients 12(6)
    • Jane Macnaughtan
    • Francesco Figorilli
    • Elisabet García-López
    • Haw Lu
    • Helen Jones
    • Rohit Sawhney
    • Kaori Suzuki
    • Sarah Fairclough
    • Joanne Marsden
    • Alba Moratella
    • I Jane Cox
    • Linda Thomas
    • Nathan Davies
    • Roger Williams
    • Raj Mookerjee
    • Gavin Wright
    • Rajiv Jalan

Study Design

Type
Randomized Controlled Trial (RCT)
Population
92 cirrhotic patients (Child-Pugh score ≤10)
Methods
randomized to receive LcS or placebo, three times daily for six months
Duration
six months
Funding
Unclear
  • Rigorous Journal
Background: In cirrhosis, a pathological gut microbiome has been linked with immune dysfunction. A pilot study of probiotic Lactobacillus casei Shirota (LcS) in alcoholic cirrhosis demonstrated significant improvement in neutrophil function. This study aimed to evaluate the efficacy of LcS on neutrophil function and significant infection rates in patients with cirrhosis. Methods: 92 cirrhotic patients (Child-Pugh score ≤10) were randomized to receive LcS or placebo, three times daily for six months. Primary end-points were incidence of significant infection and neutrophil function. Secondary end-points were cytokine profile, endotoxin, bacterial DNA positivity, intestinal permeability and quality of life. Results: Rates of infection, decompensation or neutrophil function did not differ between placebo and probiotic groups. LcS significantly reduced plasma monocyte chemotactic protein-1 and, on subgroup analysis, plasma interleukin-1β (alcoholic cirrhosis), interleukin-17a and macrophage inflammatory protein-1β (non-alcoholic cirrhosis), compared with placebo. No significant differences in intestinal permeability, bacterial translocation or metabolomic profile were observed. Conclusion: LcS supplementation in patients with early cirrhosis is safe. Although no significant infections were observed in either group, LcS improved cytokine profile towards an anti-inflammatory phenotype, an effect which appears to be independent of bacterial translocation.

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