The Effect of a Probiotic on Hepatic Steatosis

Phase 1

Terminated

• Conditions: Fatty Liver

• Registration Number: NCT00099723
• Lead Sponsor: VSL Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Status Verified: 2004-12
• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Study Completion: 2005-12
• Last Update Submitted: 2010-02-10
• Last Update Posted: 2010-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MRI
Liver biopsy
Blood work

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States