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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatty Liver

Intervention / Treatment
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* Drug: IdB 1016 (Siliphos)
* Drug: Matched placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Siliphos/Placebo<br>Received study medication first followed by placebo | Drug: IdB 1016 (Siliphos)<br>* 1 pill 3 times daily x 6 weeks<br>Drug: Matched placebo<br>* 1 pill 3 times daily x 6 weeks<br>|
| Experimental: Placebo/Siliphos<br>Received placebo first followed by study medicaiton | Drug: IdB 1016 (Siliphos)<br>* 1 pill 3 times daily x 6 weeks<br>Drug: Matched placebo<br>* 1 pill 3 times daily x 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trials, Pilot Projects, Milk Thistle, Liver Function Tests