A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH) - Full Text View

Sponsor:	University of California, San Diego
Collaborator:	American College of Gastroenterology
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00443079

Purpose

The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in people with NASH and will result in a decrease in the liver enzymes ALT and AST.

Condition	Intervention	Phase
Fatty Liver	Drug: IdB 1016 (Siliphos)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:

Drug Information available for: IdB 1016

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Safety, as determined by laboratory and clinical assessment, during and after treatment [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Tolerability, as determined by clinical assessment of side effects, during and after treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy, determined by serial measurement of serum aminotransferase levels before, during, and after treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	March 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

1 pill 3 times daily x 3 months

Detailed Description:

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. Non-alcoholic steatohepatitis (NASH) is one form of NAFLD that may progress to cirrhosis in some people. Currently, there are no medications that are approved for the treatment of NASH. Milk thistle is sold over-the-counter as a dietary supplement. Milk thistle has been used for hundreds of years as a supplement to support liver function, and is commonly taken by people with a variety of liver conditions. Milk thistle may help to reduce inflammation and fibrosis (scar tissue) in the liver, so it may be beneficial in the treatment of NASH. As NAFLD is very common in the population, there are probably many people with NAFLD taking milk thistle supplements. However, there are no published studies of milk thistle in NAFLD. Therefore, this study is designed to provide preliminary evidence of the safety, tolerability, and efficacy of milk thistle in people with NASH.

Comparison: The milk thistle supplement (called Siliphos) will be compared to a placebo (sugar pill) in this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Liver biopsy within 12 months demonstrating NASH
Abnormal ALT

Exclusion Criteria:

Uncontrolled diabetes
Hepatitis B, hepatitis C, or other chronic liver conditions
Abnormal kidney function
Excess alcohol consumption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443079

Locations

United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92103

Sponsors and Collaborators

University of California, San Diego

American College of Gastroenterology

Investigators

Principal Investigator:

Heather M Patton, MD

University of California, San Diego

More Information

Additional Information:

The American Liver Foundation has general information about fatty liver available through their website. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Kidd P, Head K. A review of the bioavailability and clinical efficacy of milk thistle phytosome: a silybin-phosphatidylcholine complex (Siliphos). Altern Med Rev. 2005 Sep;10(3):193-203. Review.

Responsible Party:	Heather Patton, MD, UCSD Medical Center
ClinicalTrials.gov Identifier:	NCT00443079 History of Changes
Other Study ID Numbers:	051117
Study First Received:	March 2, 2007
Last Updated:	June 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

Clinical Trials
Pilot Projects
Milk Thistle
Liver Function Tests

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012