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Milk Thistle for Pediatric Non-Alcoholic Fatty Liver Disease

This study is looking into whether Milk Thistle (MT), an herbal supplement, can help children and young adults with Non-Alcoholic Fatty Liver Disease (NAFLD). NAFLD is a growing problem where too much fat builds up in the liver. Participants will receive either Milk Thistle capsules or a placebo (an inactive substance like psyllium husk fiber), along with guidance on lifestyle changes like exercise and hydration. The study aims to see if Milk Thistle can improve liver health, measured by blood tests for liver enzymes (ALT) and by FibroScan, which checks liver stiffness and fat. You may be able to join if you are between 9 and 22 years old and have been diagnosed with NAFLD, with elevated ALT levels. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 20 participants. It compares Milk Thistle to a placebo, along with lifestyle modifications.
What's involved
Participants will take either Milk Thistle or placebo capsules daily, based on their weight. They will also receive instructions for physical activity and hydration, and undergo FibroScan tests.
Compensation
Not stated in the trial record.
Follow-up
Liver health will be measured up to 12 weeks after starting the study interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06477146

Milk Thistle Clinical Trial in Pediatric NAFLD

Recruiting
PHASE2Ages 9–22InterventionalTreatment
University Hospitals Cleveland Medical Center
~20 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:Milk thistle (MT)PlaceboLifestyle ModificationFibroscan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test.
Measured over Up to 12 weeks
+2 more outcomes measured

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD)

Explore related trials

Nonalcoholic Fatty Liver Disease

NCT06477146

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thomas Sferra, MD · PRINCIPAL_INVESTIGATOR · University Hospitals

Who to contact

Alok Bapatla, MD
[email protected]
(216)844-1765
Email the study team

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Eligibility criteria

Inclusion

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:
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

Exclusion

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
GGT greater than 200 U/L 4. Subjects with history or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for participation in the trial (such as poorly controlled psychiatric illness). 5. Subjects with unstable diabetes, or HbA1c \>9% will be excluded from the study. 6. Subjects who report binge drinking will be excluded from this study. 7. Subjects who partake or state consumption history of tobacco use, vaping, marijuana use, or illicit drug abuse will be excluded from the study. 8. Subjects with severe hepatic dysfunction and synthetic dysfunction with hypoalbuminemia (Albumin \< 3.0 g/dL), thrombocytopenia (platelet count \<140,000/ml3), or coagulopathy (INR \>1.4) will be excluded from the study. 9. Exclude subjects with abnormal renal function characterized as serum creatinine greater than the upper limit of normal range (based on the University of Iowa, Department of Pathology Lab Services Handbook):

What this trial measures

  • Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test.Up to 12 weeks
  • Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan.Up to 12 weeks

    Normal kPa results are usually between 2 and 7 kPa, with the highest possible result of 75 kPa.

  • Percent of Hepatic Steatosis as measured by FibroScan.Up to 12 weeks

    Percentage of steatosis will be correlated with the CAP score- 200 to 400db/m2