RiFL: Rifaxamin in Fatty Liver Disease.Does Modulation of Gut Microbiota Reduce Hepatic Inflammation in Non-Alcoholic Steatohepatitis (NASH)? - Rifaximin in Fatty Liver v2.0

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Subject has provided written informed consent prior to screening
•Men and women aged 18-70 years
•Biopsy-proven NASH with no or mild to moderate fibrosis in the preceding year
•Persistently abnormal ALT on 2 occasions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•NAFLD with cirrhosis (fibrosis score 4)
•Other causes of chronic liver disease
oViral hepatitis (HBV, HCV negative)
oAlcohol intake >14units/week (women) or >21units/week (men)
oHaemachromatosis (abnormal transferrin saturation, haemochromatosis genotyping)
•Evidence of hepatic decompensation
oAscites
oHepatic encephalopathy
oAbnormal total bilirubin (except patients with Gilbert’s syndrome), albumin, prolonged prothrombin time, low platelets)
oOesophageal or gastric varices
•Moderate or severe renal dysfunction (CKD3+, estimated GFR <60ml/min/1.73m2)
•Hepatocellular carcinoma
•Primary metabolic causes of hepatic steatosis (e.g. familial hypertriglyceridaemia, abetalipoproteinaemia)
•Other malignancy
•Pregnant or lactating women or women of childbearing potential unwilling/unable to use adequate contraceptive methods
•Systemic inflammatory conditions
oArthritis
oConnective tissue disorders
oInflammatory bowel disease
•Myocardial infarction within 6 months
•Stroke within 6 months
•Bariatric surgery/ blind loop/ short bowel
•Treatment known/suspected to change gut flora (e.g. systemic antibiotics, colestyramine, lactulose, polyethylene glycol) within 3 months
•Treatment with drugs known to cause hepatic steatosis (e.g. corticosteroids, HAART, amiodarone, high dose oestrogens, tamoxifen) within 3 months
•Initiation or major dose change of metformin, thiazolinediones, biguanides, statins, fibrates, anti-obesity medications or insulin within 3 months of enrolment
•Patients with allergy to Rifaximin or Rifamycin
•Patients with a cardiac pacemaker, history of penetrating eye injury, metal foreign body or any other contra-indication to MRI scanning, as specified in the local MRI safety checklist
•Any other clinical, social or psychological issues which, in the opinion of the investigators may preclude satisfactory completion of the study protocol