The Effect of Probiotic and/or Prebiotic on Liver Function Tests in Patients with Nonalcoholic Fatty Liver Disease: A Double Blind Randomized Clinical Trial

Background: Oral administration of pro-and prebiotics has recently been considered as an effective way for nonalcoholic fatty liver disease (NAFLD) recovery. Objectives: The current study aimed at evaluating the effect of supplementation with probiotics and/or prebiotics on liver function tests in patients with NAFLD. Methods: In this double blind, placebo-control clinical trial, 75 subjects with NAFLD were voluntarily recruited from May 2013 to March 2014, in Iran. Participants were randomly assigned to 1 of 4 groups using a block randomization procedure. Group 1 received probiotic capsules (Bifidobacterium longum (BL) and Lactobacillus acidophilus (LA): 2 x 10(7) CFU/day), group 2 received prebiotic inulin high performance (HP): 10 g/day, group 3 received probiotic and the prebiotic, and group 4 received a placebo for 3 months. The sample size was determined on the basis of a primary outcome of a change in aspartate aminotransferase (AST) level. Results: Anintergroup comparison indicated that the AST (P =0.006) and alanine aminotransferase (ALT) (P = 0.04) levels decreased at the end of the study. Aspartate Aminotransferase (mean difference of group1 versus placebo with P value of 0.001, group2 versus placebo with P value of 0.045, group3 versus placebo with P value of 0.015) and ALT (mean difference of group 1 versus placebo with P value of 0.009, group 2 versus placebo with P value of 0.041, and group 3 versus placebo with P value of 0.046) serum levels decreased significantly in all of the intervention groups compared to the placebo. The grade of fatty liver in group 1 (P of 0.027, and number needed to treat (NNT) = 3) and group 3 (P = 0.019 and NNT = 3) decreased compared to the placebo group with no significant changes in group 2. Conclusions: Supplementation with probiotics and/or prebiotics improved aminotransferase enzymes,and supplementation with probiotics or pro-and prebiotics recovered the grade of fatty liver in NAFLD patients.