Effect of Pre/Probiotic Mixture in Children with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Background: The prevalence of pediatric nonalcoholic fatty liver disease (NAFLD) has been increasing worldwide in parallel with the obesity epidemic. Dysbiosis of gut microbiota is implicated in the pathogenesis of NAFLD.

Objective: This study aimed to investigate the effect of pre/probiotic mixture treatment in children with NAFLD.

Methods: This was a randomized, double-blind, placebo-controlled trial conducted between February and October 2016. NAFLD was defined by controlled attenuation parameter (CAP) value of greater than 250 dB/m without other causes of fatty liver. Participants received either a mixture of chicory inulin, Lactobacillus acidophilus, and Bifidobacterium lactis or placebo for 16 weeks. Body mass index (BMI), serum alanine transaminase (ALT), and liver stiffness measurement (LSM) with simultaneous controlled attenuation parameter (CAP) determination using the FibroScan^® were assessed at baseline and after the completion of the intervention. BMI Z-score adjusted for age and sex was determined according to the 2007 WHO child growth references.

Results: There were 18 (78% male) and 19 children (58% male) in intervention and placebo groups. The number of children aged ≤ 9 and > 9 years were not significantly different between the two groups. Baseline mean (SD) of BMI Z-score, serum ALT, CAP, and LSM of enrolled participants were 2.9 (0.7), 51.8 (41.6) U/L, 312.8 (38.3) dB/m, and 6.1 (3.5) kPa. After the completion of the intervention, BMI Z-score significantly decreased in both groups. The reduction of CAP value was significant only in the placebo group (P=0.04). The median between-group difference in change from baseline (interquartile range) for BMI Z-score, serum ALT, CAP, and LSM values were -0.0 (-0.1, -0.1), -1.7 (-19.4, 16.1) U/L, 5.74 (-22.8, 34.3) dB/m, and 0.2 (-0.5, 0.9) kPa, which were not statistically significant.

Conclusion: The present study is unable to demonstrate the beneficial effect of this particular pre/probiotic mixture on BMI and hepatic derangement in children with NAFLD.