Clinical trial NCT00443079: A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Official title: A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatty Liver
Keywords: Clinical Trials
Pilot Projects
Milk Thistle
Liver Function Tests
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2007-03-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Study Participants With Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With a Decrease in ALT Value Greater Than or Equal to 15 U/L From Baseline to the End of the Treatment Era
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Heather M Patton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.