Actively Recruiting
Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)
Led by University Hospitals Cleveland Medical Center · Updated on 2026-01-27
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD) is an increasing health concern in the United States and is expected to become a leading reason for liver transplantation in adults within 20 years. This trial is studying an herbal supplement called Milk Thistle to see if it can improve fatty liver disease in children and young adults. Milk Thistle may offer an easier alternative to lifestyle changes like diet and exercise, which can be hard to maintain consistently. Participants will be randomly assigned to receive either Milk Thistle capsules or placebo capsules, taken by mouth once or twice daily for 12 weeks. The Milk Thistle capsules contain a standardized extract, and dosing is based on body weight with a maximum of 600 mg per day. Along with the capsules, participants will receive lifestyle modification guidance focusing on physical activity, hydration, and dietary recommendations. Liver stiffness and fat content will be measured using FibroScan, a non-invasive device. During the trial, participants will have blood tests to measure liver enzymes and undergo FibroScan to assess liver health at the start and after 12 weeks. Researchers will also monitor any side effects reported by patients. The main outcomes include changes in liver enzyme levels, liver stiffness, and fat percentage. The study will last about 12 weeks, with ongoing safety monitoring. Participants are expected to follow the treatment and lifestyle advice and attend scheduled assessments.
CONDITIONS
Brief Title
Milk Thistle Clinical Trial in Pediatric NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 9 and 22 years old
- Diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD) based on current guidelines
- Elevated ALT levels greater than 2 times sex-specific upper limit (boys >50 U/L, girls >44 U/L)
- Overweight or obese children defined by BMI percentiles or adults by BMI kg/m2 thresholds
- Evidence of hepatic steatosis greater than 5% by ultrasound or FibroScan (CAP score ≥238) prior to trial
- Previous liver biopsy showing NAFLD features may qualify
- Females of reproductive potential must have negative pregnancy test, not breastfeeding, and agree to effective contraception
- Males sexually active with partners of childbearing potential must agree to contraception and sperm donation restrictions
You will not qualify if you...
- History of cardiovascular disorders such as myocardial infarction, stroke, or deep vein thrombosis
- History of malignancy, transplantation, immunologic diseases, poorly controlled thyroid disease, or uncontrolled hypertension
- Cirrhosis or hepatic decompensation; abnormal liver biomarkers beyond specified thresholds
- Severe illness or conditions deemed unsuitable by investigator
- Unstable diabetes or HbA1c over 9%
- Binge drinking history
- Use of tobacco, vaping, marijuana, or illicit drugs
- Severe hepatic dysfunction with hypoalbuminemia, thrombocytopenia, or coagulopathy
- Abnormal renal function above specified creatinine limits
- Breastfeeding women
- Participation in other drug trials
- Known allergy or anaphylactic reaction to Ragweed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take Milk Thistle or placebo capsules based on weight once or twice daily and follow lifestyle modification instructions including physical activity and dietary guidelines.
Visits scheduled to monitor treatment progress and collect measurements including blood tests and FibroScan assessments
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
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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