Histological Improvement of NASH With Prebiotic

Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial

This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8 g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary outcome measure is the change in liver biopsy NAS score and the secondary outcomes include changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory markers, and gut microbiota.

Oligofructose and maltodextrin are both white powders that taste and look the same. They were both package in individual foil packets. Participants were blinded to the treatment allocation. Adherence to supplement protocol was monitored throughout the study through direct questioning and counting unused supplement packages. Participants were asked to maintain their usual physical activity.

Inclusion Criteria:

• Liver biopsy confirmed NASH (NAS score greater than or equal to 5)
• BMI >25 kg/m2 (Caucasians)
• >23 kg/m2 (Asians)
• History of Serum ALT >1.5X upper normal limit
• No changes in lipid-lowering or diabetes medication over previous three months
• Ability to provide informed consent

Exclusion Criteria:

• alcohol consumption >20g/day (women) or >30g/day (men)
• alternate etiology for abnormal liver enzymes
• decompensated liver disease
• use of orlistat, liraglutide, prebiotic, probiotic, or antibiotic within 3 months prior to enrollment