Milk Thistle Clinical Trial in Pediatric NAFLD

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06477146
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-Alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Sex
ALL
Age
9 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Milk thistle (MT) — DRUG
    MT capsules will contain 300 mg of MT with 80% content of Silymarin, standardized to 240mg Silymarin content. Dosing will be based on body weight with maximum dose of 600 mg/day. Dosing will be either 1 or 2 capsules per day based on weight.
  • Placebo — DRUG
    The placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition.
  • Lifestyle Modification — BEHAVIORAL
    The primary instructions for lifestyle modification are: 1. Physical activity goal- 20-30 minutes per day 5 to 7 days per week. The aim is 150 minutes a week and more than 300 calories burnt for each workout. 2. Adequate hydration- 4-5 bottles of water a day. 3. Limitation of sugar-free beverages- once daily and 1-2 (8 oz) cups of skim/1% milk (or dairy alternative) daily. 4. Avoidance of beverages with added sugar such as soda, Kool-Aid, juice, and Gatorade. 5. Ideal consumption- three meals daily(breakfast, lunch, dinner)and one snack. 6. Snack Goal \<200 calories. If a 2nd, 3rd, etc. snack is desired it will only be a vegetable. 7. Five servings of fruits/vegetables per day. 8. Each food we recommend eating should have dietary fiber \>3 grams/serving. Ideally \>5 grams/serving. 9. The given survival guide will have all information regarding serving size and portion allotment. 10. "MyPlate.gov" handout given which will guide participants in relation to portion control.
  • Fibroscan — DEVICE
    FibroScan will be completed to measure Elastography. Elastography works by emitting small pulse of energy which may be perceived as a vibration which quickly calculated the stiffness of the liver, which correlates to fat deposition and fibrosis.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Milk Thistle
    Patients will be given Milk Thistle capsules based on weight by mouth once or twice daily for 12 weeks.
  • Experimental: Placebo
    Patients will be give 500mg capsule based on weight by mouth once or twice daily for 12 weeks.

Primary Outcome Measure

Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test. [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Alok Bapatla, MD
[email protected]
(216)844-1765

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By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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