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

Fatty Liver Clinical Trial

Official title:

A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443079
• Other study ID #: 051117
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• IdB 1016 (Siliphos)
1 pill 3 times daily x 6 weeks
• Matched placebo
1 pill 3 times daily x 6 weeks

Locations

Country	Name	City	State
United States	University of California, San Diego Medical Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Heather Patton	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Participants With Adverse Events	Side effect profile was collected at each study visit as tracked by study participants. Any new onset symptoms reported by study participants were recorded as side effects of treatment and analyzed according to whether they occurred while participants were treated with placebo or Siliphos.; An increase in ALT value to greater than or equal to 2 x baseline value was also evaluated for possible drug induced liver injury.	6 weeks
Secondary	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	Change in ALT value from baseline to end of treatment arm during the time treated with Placebo in comparison to the time treated with Siliphos. Significant change in ALT was defined as a decrease by 15 or more units from baseline to end of treatment period.	6 weeks