The Effect of a Probiotic on Hepatic Steatosis

VSL Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Fatty Liver

Treatments: Drug: VSL#3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099723

R21AT001305-01 (U.S. NIH Grant/Contract)

SS01305-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There are multiple exclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind