The Effect of a Probiotic on Hepatic Steatosis

Stopped early · Phase 1

Conditions studied: Fatty Liver

In brief

Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Key facts

Study ID

NCT00099723

Run by

VSL Pharmaceuticals

People needed

30

Starts

2004-10-01

Expected to finish

2005-12-01

Last updated by the study team

2010-02-11

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult-onset diabetes
• Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3

You may not qualify if…

• There are multiple exclusion criteria.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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