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Bifidobacterium longum with Fructo-Oligosaccharides in Patients with Non Alcoholic Steatohepatitis

  • 2011-09-08
  • Digestive Diseases and Sciences 57(2)
    • M. Malaguarnera
    • M. Vacante
    • T. Antić
    • M. Giordano
    • G. Chisari
    • R. Acquaviva
    • S. Mastrojeni
    • G. Malaguarnera
    • A. Mistretta
    • G. Volti
    • F. Galvano

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 66
Population
Patients with non-alcoholic steatohepatitis (NASH)
Methods
Randomized Controlled Trial
  • Highly Cited
  • Rigorous Journal

Abstract

Background: Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis (NASH). Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota.

Aims: To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides (Fos) in the treatment of NASH.

Methods: A total of 66 patients were randomly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification (i.e., diet and exercise) versus lifestyle modification alone. The following variables were assessed at -4 (beginning of the dietary lead-in period), 0 (randomization), 6, 12, 18, and 24 weeks: aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, albumin, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, fasting plasma glucose, insulin, C-peptide, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, homeostasis model assessment of insulin resistance (HOMA-IR), and serum endotoxins. Liver biopsies were performed at entry and repeated after 24 weeks of treatment.

Results: At the end of study period, we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST -69.6 versus -45.9 IU/mL (P < 0.05), LDL cholesterol -0.84 versus -0.18 mmol/L (P < 0.001), CRP -2.9 versus -0.7 mg/L (P < 0.05), TNF-α -0.45 versus -0.12 ng/mL (P < 0.001), HOMA-IR -1.1 versus -0.6 (P < 0.001), serum endotoxin -45.2 versus -30.6 pg/mL (P < 0.001), steatosis (P < 0.05), and the NASH activity index (P < 0.05).

Conclusions: Bifidobacterium longum with Fos and lifestyle modification, when compared to lifestyle modification alone, significantly reduces TNF-α, CRP, serum AST levels, HOMA-IR, serum endotoxin, steatosis, and the NASH activity index.

Research Insights

  • Bifidobacterium longum MAK34B12L→Improved Insulin Sensitivity

    At the end of study period, we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the... HOMA-IR -1.1 versus -0.6 (P < 0.001)

    Effect
    Beneficial
    Effect size
    Large
  • Bifidobacterium longum MAK34B12L→Improved Liver Steatosis

    At the end of study period, we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the... steatosis (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
  • Bifidobacterium longum MAK34B12L→Reduced AST Levels

    Bifidobacterium longum with Fos and lifestyle modification ... significantly reduces ... serum AST levels ... -69.6 versus -45.9 IU/mL (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
  • Bifidobacterium longum MAK34B12L→Reduced C-Reactive Protein Levels

    At the end of study period, we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the... CRP -2.9 versus -0.7 mg/L (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
  • Bifidobacterium longum MAK34B12L→Reduced LDL Cholesterol

    At the end of study period, we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in LDL cholesterol -0.84 versus -0.18 mmol/L (P < 0.001)

    Effect
    Beneficial
    Effect size
    Large
  • Bifidobacterium longum MAK34B12L→Reduced NASH Activity

    significant differences in the NASH activity index (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
  • Bifidobacterium longum MAK34B12L→Reduced Serum Endotoxin Level

    Serum endotoxin -45.2 versus -30.6 pg/mL (P < 0.001)

    Effect
    Beneficial
    Effect size
    Large
  • Bifidobacterium longum MAK34B12L→Reduced TNF-α Levels

    Bifidobacterium longum with Fos and lifestyle modification ... significantly reduces TNF-α ... -0.45 versus -0.12 ng/mL (P < 0.001)

    Effect
    Beneficial
    Effect size
    Large
  • bifidobacterium longum→Improved Insulin Resistance

    we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST -69.6 versus -45.9 IU/mL (P < 0.05), LDL cholesterol -0.84 versus -0.18 mmol/L (P < 0.001), CRP -2.9 versus -0.7 mg/L (P < 0.05), TNF-α -0.45 versus -0.12 ng/mL (P < 0.001), HOMA-IR -1.1 versus -0.6 (P < 0.001), serum endotoxin -45.2 versus -30.6 pg/mL (P < 0.001), steatosis (P < 0.05), and the NASH activity index (P < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
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