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. 2019 May 31;50(2):144–158. doi: 10.1111/apt.15314

Table 2.

Human studies of nonsystemic antibiotics for NAFLD

Publication Study population Study design/treatments Primary outcomes
Cobbold et al 2017145 Adults with histologically confirmed NAFLD OL rifaximin 400 mg b.i.d. for 6 wk (n = 15)

  • No significant alterations from baseline in ALT, hepatic lipid content, hepatic insulin sensitivity or serum cytokine (TNF‐α and IL‐1β) after 6 wk

  • ALT (P = 0.017), HDL (P = 0.004) and HOMA‐IR (P = 0.05) levels significantly increased from baseline to week 12 (ie, during the 6‐wk post‐treatment period)

  • No consistent differences were observed in faecal microbiota composition at the phylum level

  • Significant reduction in urinary hippurate levels with rifaximin treatment (P = 0.048) was reported, indicating possible alteration in gut microbiota metabolism
Gangarapu et al 2015146 Adults with histologically confirmed NAFLD (steatosis, n = 15; NASH, n = 27) OL rifaximin 1200 mg/d for 4 wk (n = 42)

  • At 4 wk post‐treatment, rifaximin significantly reduced levels of ALT (P = 0.01) and ferritin (P = 0.004) from baseline in patients with steatosis

  • In patients with NASH, rifaximin significantly reduced BMI, ALT, AST, GGT, LDL and ferritin levels, plasma endotoxin concentrations and serum IL‐10 levels from baseline to 4 wk post‐treatment (P ≤ 0.01 for all)

  • No changes in serum TNF‐α, IL‐1, IL‐6, IL‐12 or TLR‐4 levels were observed in either patient group
Kakiyama et al 2013147 Adult patients with “early” cirrhosis (Child‐Pugh Class A without history of decompensation) Longitudinal sub study; rifaximin 550 mg b.i.d. for 8 wk (n = 6)

  • Reduction in ratio of secondary BAs to primary BAs after rifaximin treatment

  • No significant change in bacteria composition of the gut microbiota, except for reduction in Veillonellaceae

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; b.i.d., twice daily; BA, bile acid; BMI, body mass index; GGT, gamma‐glutamyl transferase; HDL, high‐density lipoprotein; HOMA‐IR, homeostasis model assessment‐insulin resistance; IL, interleukin; LDL, low‐density lipoprotein; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; OL, open label; TLR, toll‐like receptor; TNF‐α, tumour necrosis factor alpha.