Rifaximin in Fatty Liver v2.0

• Research type

  Research Study

• Full title

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

• IRAS ID

  45706

• Contact name

  Quentin M Anstee

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Eudract number

  2010-021515-17

• ISRCTN Number

  N/A

• Research summary

  Fatty liver (non-alcoholic fatty liver disease, NAFLD) is the most common cause of liver dysfunction in the western world. It is associated with diabetes and obesity and can progress to liver fibrosis (scarring), cirrhosis, liver cancer and death. Bacteria in the bowel (gut microbiota) play an important role in health and disease. With respect to fatty liver, the toxins from the bacteria can cross from the bowel to the bloodstream, leading to inflammation in the liver and increasing resistance to the main energy storage hormone, insulin. Furthermore, bacteria can ferment some dietary components, producing more absorbable nutrients and alcohols, which may be carried to the liver and can cause increased fat and inflammation. Animal studies have indicated that changing the gut microbiota can reduce the bacterial toxins produced and decrease obesity. Recent work in our laboratory has shown that giving antibiotics to mice with fatty liver reduces inflammation.In this pilot study, we propose that altering the gut microbiota of people with non-alcoholic fatty liver disease will reduce the inflammation in the liver. We will use an antibiotic, Rifaximin, which is not absorbed through the gut, thus confining its effects to the contents of the bowel. Rifaximin is licensed for use in travellers?? diarrhoea in the United States. It has also been used in many other research studies and the observed side effects are uncommon and mild.We will measure response to the alteration of the gut bacteria in terms of changes in markers of liver inflammation, liver fat, and resistance to insulin in the liver. We will also measure the numbers of bacterial families in the bowel from faeces, and products of their metabolism in the urine.The information gathered in this pilot study may enable establishment of a longer term, randomised, placebo-controlled study of Rifaxamin to treat non-alcoholic fatty liver disease.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/58

• Date of REC Opinion

  23 Aug 2010

• REC opinion

  Further Information Favourable Opinion