Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

Prior treatment

• Previous antibiotic/antifungus within 1 month
• Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
• Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone

Other illness

• History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
• Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
• Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
• Active malignancy on treatment
• Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections

Lab values

• Hepatic decompensation or impairment defined as presence of any of the following:
  • History of esophageal varices, ascites or hepatic encephalopathy.
  • Serum albumin \<3.5 g dl-1, except as explained by nonhepatic causes.
  • INR \> 1.4
• New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
• Severe renal impairment (eGFR \<30 ml/min/1.73 m2)

Other

• Supplement with probiotic/prebiotic within 2 weeks
• Respiratory compromised
• Pregnancy

• Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD