Milk Thistle Clinical Trial in Pediatric NAFLD
Eligible age
9–22 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.
Sponsor: University Hospitals Cleveland Medical Center
You may qualify if…
- ✓ Subjects between the age of 9 to 22 years old diagnosed with non-Alcoholic Fatty Liver Disease (NAFLD) based on current North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Guidelines:
- ✓ a. Elevated ALT levels greater than 2 times the sex specific upper limit of normal at baseline; (for boys ALT greater than 50 U/L, and girls ALT greater than 44 U/L) i. AND either overweight (with risk factors as noted below) or obese children:
- ✓ 1\. In children, obesity is defined as BMI greater than or equal to 95th percentile in weight and overweight is defined as greater than or equal to the 85th percentile to less than the 95th percentile.
- ✓ 2\. Risk factors associated with overweight child that warrant screening and inclusion are:
- ✓ a. Central obesity, Family history of NAFLD/non-alcoholic steatohepatitis(NASH), pre-diabetic or diabetic, dyslipidemia, sleep apnea)
- ✓ 3\. For participants 18 years or older: Obesity is defined as BMI greater than or equal to 30 kg/m2; overweight is defined as BMI greater than or equal to 25 kg/m2 and less than 30 kg/m2.
- ✓ b. Evidence of Sonographic presence of hepatic steatosis with greater than 5% steatosis on Ultrasound or FibroScan \[with a controlled attenuation parameter (CAP) score of 238 or greater)\] prior to start of trial starting.
- ✓ c. (Or) previous findings on Liver Biopsy consistent with NAFLD including hepatic macro-vesicular steatosis, ballooning degeneration or Mallory Denk Bodies
You may not qualify if…
- ✕ 1. Patients with cardiovascular disorders (such as history of myocardial infarction, stroke, DVT)
- ✕ 2. Medical conditions including history of malignancy, transplantation, immunologic diseases (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, autoimmune thyroiditis, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis etc.), poorly controlled thyroid disease, uncontrolled hypertension.
- ✕ 3. Patients with cirrhosis and hepatic decompensation will be excluded from the study. Hepatic biomarker parameters will be excluded:
- ✕ ALT greater than 200 U/L
- ✕ AST greater than 200 U/L
- ✕ Total bilirubin greater than 2.0 mg/dL
- ✕ ALP greater than 500 U/L
- ✕ INR greater than 1.4
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT06477146 · last updated 2026-01-27