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Herbal Supplement

Milk Thistle for Pediatric Fatty Liver Disease

Phase 2
Recruiting
Led By Thomas Sferra, MD
Research Sponsored by Thomas J Sferra, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Contraception Requirements for Enrollment of adult population: Female participants are eligible if the participant is of reproductive potential and have a negative serum pregnancy test, are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if the participant is not of child-bearing potential
Previous findings on Liver Biopsy consistent with NAFLD including hepatic macro-vesicular steatosis, ballooning degeneration or Mallory Denk Bodies
Must not have
Patients with cirrhosis and hepatic decompensation
Subjects who partake or state consumption history of tobacco use, vaping, marijuana use, or illicit drug abuse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks

Summary

This trial aims to explore the use of an herbal supplement called Milk Thistle as a potential alternative treatment for Pediatric Fatty Liver disease. The goal is to find a solution that may be easier to follow

Who is the study for?
This trial is for children with a condition called non-alcoholic fatty liver disease (NAFLD). They should not have other serious health issues. The study aims to find out if Milk Thistle, an herbal supplement, can help improve their liver health.
What is being tested?
The trial is testing the effectiveness of Milk Thistle compared to a placebo in improving NAFLD in kids. Participants will also undergo Fibroscan tests and be advised on lifestyle modifications like diet and exercise.
What are the potential side effects?
Milk Thistle is generally considered safe but may cause digestive upset, allergic reactions, or headaches. It's important to monitor any side effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, breastfeeding, or planning to become pregnant and will use two forms of birth control if of childbearing potential.
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My liver biopsy showed signs of fatty liver disease.
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I am aged 9-22 and diagnosed with NAFLD according to specific guidelines.
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My ALT levels are high and I am overweight or obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cirrhosis with worsening liver function.
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I have used tobacco, vaped, used marijuana, or abused drugs.
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My kidney function is normal.
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I do not have a history of serious illnesses like cancer, immune diseases, or uncontrolled high blood pressure.
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My diabetes is not under control, or my HbA1c is above 9%.
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I have severe liver problems with low albumin, low platelets, or clotting issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan.
Percent of Hepatic Steatosis as measured by FibroScan.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment3 Interventions
Patients will be give 500mg capsule based on weight by mouth once or twice daily for 12 weeks.
Group II: Milk ThistleExperimental Treatment3 Interventions
Patients will be given Milk Thistle capsules based on weight by mouth once or twice daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Modification
2006
Completed Phase 4
~2280
Placebo
1995
Completed Phase 3
~2670
Fibroscan
2016
N/A
~1140

Find a Location

Who is running the clinical trial?

Thomas J Sferra, MDLead Sponsor
Thomas Sferra, MDPrincipal InvestigatorUniversity Hospitals
1 Previous Clinical Trials
23 Total Patients Enrolled
~13 spots leftby Jan 2026
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