Actively Recruiting
Milk Thistle Clinical Trial in Pediatric NAFLD
Led by University Hospitals Cleveland Medical Center · Updated on 2026-01-27
20
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Milk Thistle Clinical Trial in Pediatric NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 9 and 22 years old
- Diagnosed with non-Alcoholic Fatty Liver Disease (NAFLD) based on accepted guidelines
- Elevated ALT levels greater than 2 times sex-specific upper limit (boys >50 U/L, girls >44 U/L)
- Overweight or obese status defined by BMI percentiles for children or BMI thresholds for adults
- Evidence of hepatic steatosis greater than 5% by ultrasound or FibroScan (CAP score 68 or higher) before starting the trial
- Or liver biopsy showing NAFLD features like macro-vesicular steatosis or ballooning degeneration
- Adult females of reproductive potential must have negative pregnancy test and agree to use two effective birth control methods or be naturally or surgically sterile
- Adult males sexually active with partners of child-bearing potential must agree to use birth control or abstain from sexual intercourse during the study
You will not qualify if you...
- History of cardiovascular disorders such as heart attack, stroke, or deep vein thrombosis
- History of malignancy, organ transplantation, or immunologic diseases like rheumatoid arthritis or lupus
- Poorly controlled thyroid disease or hypertension
- Cirrhosis or hepatic decompensation indicated by severe liver test abnormalities
- Severe illness or psychiatric conditions making participation unsuitable
- Unstable diabetes or HbA1c greater than 9%
- History of binge drinking
- Use of tobacco, vaping, marijuana, or illicit drugs
- Severe liver dysfunction with low albumin, low platelets, or high INR
- Abnormal kidney function above normal creatinine levels for age and sex
- Breastfeeding women
- Participation in other drug trials
- Allergy or severe reaction to Ragweed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
A
Alok Bapatla, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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