Health Trials

Milk Thistle Clinical Trial in Pediatric NAFLD

ConditionNon-Alcoholic Fatty Liver Disease (NAFLD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-22
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

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

Disqualifiers

Patients with cardiovascular disorders (such as history of myocardial infarction, stroke, DVT)

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.

ALT greater than 200 U/L

AST greater than 200 U/L

Trial design

Treatments tested in this trial

  • Milk thistle (MT)
  • Placebo
  • Lifestyle Modification
  • Fibroscan

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov