Probiotics Do Not Alter Liver Function Markers and Clinical Parameters in Patients With Nonalcoholic Steatohepatitis and Low Degree of Fibrosis

Abstract

ObjectivesEvaluate the effect of probiotic supplementation on liver function markers, and clinical parameters, in nonalcoholic steatohepatitis (NASH) patients. MethodsThis double-blind, randomized clinical trial included adult outpatients with biopsy-proven NASH. The intervention: 24 weeks of supplementation with probiotic mix (Lactobacillus acidophillus + Bifidobacterium lactis + Lactobacillus rhamnosus + Lactobacillus paracasei, 1 × 109 CFU for each) or placebo, twice a day. At baseline and 24-weeks after treatment, the following parameters were evaluated: demographic and clinical data, hepatic enzymes, laboratory assessment, serum concentration of toll-like receptor-4 (TLR-4), cytokeratin 18 (CK-18) biomarker and anthropometric data assessment. ResultsForty-four patients completed the trial (51.4 ± 11.6 years, 59% women). At baseline, 87% had low hepatic fibrosis degree (26% F0; 61% F1 at biopsy), values of hepatic enzymes close to normal [AST 32 (24–46) U/L, ALT 42 (28–63) U/L, GGT 46 (28–84) U/L], increased waist circumference (104.7 ± 12 cm), body mass index (BMI) with obesity classification 30.97 (28.36–33.75) kg/m2 and 76% with Metabolic Syndrome (MetS). After 24 weeks, no differences were observed between the Probiotic and Placebo groups in the components of the MetS, waist circumference, BMI or liver enzymes (P > 0.05 for all). CK-18 was reduced in both groups after the intervention: in the probiotic group from 981.09 (738.34–1134.73) to 639.46 (509.50–817.23) mIU/ml (P ≤ < 0.01) and in the placebo group from 789.74 (540.80–985.65) to 605.45 (472.13–837.22) mIU/ml (P = 0.013), however with no significant difference between groups (P = 0.109). Likewise, TLR-4 was reduced in both groups after the intervention, also with no difference between groups (P = 0.885). ConclusionsThe intervention with probiotics for 24 weeks in patients with NASH with low degree of fibrosis demonstrated to be unable to promote significant changes in the reduction of liver injury and inflammation biomarkers, nutritional and clinical parameters. Funding SourcesResearch and Events Fund from the Hospital de Clínicas de Porto Alegre (FIPE), Coordination for the Improvement of Higher Education Personnel (CAPES/PROAP), National Council for Scientific and Technological Development – Brazil (CNPq).