Fatty Liver
Conditions
Keywords
Clinical Trials, Pilot Projects, Milk Thistle, Liver Function Tests
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.
Interventions
DRUGIdB 1016 (Siliphos)
1 pill 3 times daily x 6 weeks
DRUGMatched placebo
1 pill 3 times daily x 6 weeks
Sponsors
American College of Gastroenterology
Heather Patton
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants With Adverse Events | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Adults with biopsy-proven NASH were recruited from outpatient hepatology clinics. Liver biopsy had to be within the previous year (no liver biopsies were done specifically to enroll in the study). ALT was elevated (normal ALT defined as 30U/L for men and 20U/L for women) and other types of chronic liver disease (viral hepatitis, alcohol, autoimmune) evaluated and excluded. Baseline kidney function was also normal (creatinine less than or equal to 1).
Pre-assignment details
There were no participants who were excluded from study between informed consent/screening visit and study group allocation/randomization.
Participants by arm
| Arm | Count |
|---|---|
| Siliphos/Placebo Subjects treated with Siliphos (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by placebo (1 pill by mouth three times daily) for 6 weeks | 3 |
| Placebo/Siliphos Subjects treated with Placebo (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by Siliphos (1 pill by mouth three times daily) for 6 weeks | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Siliphos/Placebo | Placebo/Siliphos | Total |
|---|---|---|---|
| Age, Customized Age <50 years | 6 participants | 6 participants | 12 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: 6 weeks
Population: side effects and adverse events were gathered from study participants at each clinic visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Siliphos | Number of Study Participants With Adverse Events | 0 Participants |
| Placebo | Number of Study Participants With Adverse Events | 0 Participants |
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.
Time frame: 6 weeks
Population: Number participants with a decrease in ALT value greater than or equal to 15 U/L from baseline to the end of the treatment era.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Siliphos | 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 | 0 Participants |
| Placebo | 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 | 0 Participants |