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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01355575 |
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Date of registration:
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17/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rifaximin in Fatty Liver Disease
RiFL |
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Scientific title:
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RiFL: Rifaximin in Fatty Liver Disease. Does Modulation of Gut Microbiota Reduce Hepatic Inflammation in Non-Alcoholic Steatohepatitis (NASH)? |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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15 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01355575 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jeremy FL Cobbold, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Name:
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Mark R Thursz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has provided written informed consent prior to screening
- Men and women aged 18-70 years
- With non-alcoholic steatohepatitis histologically-proven, as evidenced by the presence
of all of: steatosis, hepatocyte ballooning and lobular inflammation, and scored
according to Kleiner(18) by a single experienced histopathologist (RDG) within the
previous year, with or without mild to moderate fibrosis (stage 0-3/4)
- With persistently elevated alanine aminotransferase (ALT) values on at least two
occasions in the three months prior to recruitment
Exclusion Criteria:
- NAFLD with cirrhosis (fibrosis score 4)
- Other causes of chronic liver disease
- Viral hepatitis (HBV, HCV negative)
- Alcohol intake >14units/week (women) or >21units/week (men)
- Haemachromatosis (abnormal transferrin saturation, haemochromatosis genotyping)
- Evidence of hepatic decompensation
- Ascites
- Hepatic encephalopathy
- Abnormal total bilirubin (except patients with Gilbert's syndrome), albumin,
prolonged prothrombin time, low platelets)
- Oesophageal 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
- Arthritis
- Connective tissue disorders
- Inflammatory 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, thiazolidinediones, 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nonalcoholic Fatty Liver Disease
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Nonalcoholic Steatohepatitis
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NAFLD
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Intervention(s)
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Drug: Rifaximin
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Primary Outcome(s)
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Serum Alanine Aminotransferase (ALT) Levels
[Time Frame: Baseline, 6 weeks (end of treatment) and 12 weeks (6 weeks after end of treatment)]
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Secondary Outcome(s)
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Insulin Resistance
[Time Frame: Baseline and 6 weeks (end of treatment)]
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Hepatic Triglyceride Content
[Time Frame: Baseline and 6 weeks (end of treatment)]
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Secondary ID(s)
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45706
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10/H0711/58
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2010-021515-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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