Milk Thistle for Pediatric Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Overseen byThomas Sferra, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Thomas J Sferra, MD
Disqualifiers: Cardiovascular disorders, Malignancy, Transplantation, Immunologic diseases, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Milk Thistle for Pediatric Fatty Liver Disease?
Research shows that silymarin, the active component of milk thistle, has antioxidant, anti-inflammatory, and antifibrotic properties, which have been beneficial in treating liver diseases like nonalcoholic fatty liver disease (NAFLD) in adults. Some studies have demonstrated that silymarin can improve liver conditions by reducing liver fat, inflammation, and damage.
12345Is milk thistle safe for humans?
Milk thistle is generally considered safe and well-tolerated in humans, with only mild side effects like stomach upset and rare allergic reactions reported when taken within recommended doses.
12567How is milk thistle treatment different for pediatric fatty liver disease?
Milk thistle is unique for pediatric fatty liver disease because it contains silymarin, which has antioxidant and liver-protecting properties, and there are currently no standard drug treatments for this condition. It has been used historically for various liver diseases, suggesting potential benefits, but more research is needed to confirm its effectiveness in children.
12568Eligibility Criteria
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.Inclusion Criteria
I am not pregnant, breastfeeding, or planning to become pregnant and will use two forms of birth control if of childbearing potential.
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
My liver biopsy showed signs of fatty liver disease.
+2 more
Exclusion Criteria
I do not have a history of serious illnesses like cancer, immune diseases, or uncontrolled high blood pressure.
My diabetes is not under control, or my HbA1c is above 9%.
I have a history of heart or blood vessel problems.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Milk Thistle or placebo capsules based on weight by mouth once or twice daily
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
Thomas J Sferra, MDLead Sponsor
University Hospitals Cleveland Medical CenterLead Sponsor
References
In vivo efficacy study of milk thistle extract (ETHIS-094™) in STAM™ model of nonalcoholic steatohepatitis. [2023]A subcategory of nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) is characterized by accumulation of fat accompanied by inflammatory infiltration and hepatocellular damage. The active complex of milk thistle is a lipophilic extract from its seeds, comprising three isomers, collectively known as silymarin. Silymarin has demonstrated antioxidant, anti-inflammatory, and antifibrotic properties, and has been extensively studied in the treatment of liver diseases. The majority of published clinical research on silymarin has used Legalon(®) (Rottapharm/Madaus), containing the patented extract of milk thistle ETHIS-094™ (Euromed). The current study was undertaken to examine the effects of ETHIS-094™ in the Stelic Animal Model (STAM™), a validated and widely used animal model for NASH.
Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. [2023]Milk thistle (MT; Silybum marianum), a member of the Asteraceae family, is a therapeutic herb with a 2,000-year history of use. MT fruits contain a mixture of flavonolignans collectively known as silymarin, being silybin (also named silibinin) the main component. This article reviews the chemistry of MT, the pharmacokinetics and bioavailability, the pharmacologically relevant actions for liver diseases (e.g., anti-inflammatory, immunomodulating, antifibrotic, antioxidant, and liver-regenerating properties) as well as the clinical potential in patients with alcoholic liver disease, nonalcoholic fatty liver disease, viral hepatitis, drug-induced liver injury, and mushroom poisoning. Overall, literature data suggest that, despite encouraging preclinical data, further well-designed randomized clinical trials are needed to fully substantiate the real value of MT preparations in liver diseases.
Phytotherapy and NAFLD--from goals and challenges to clinical practice. [2023]Non-alcoholic fatty liver disease (NAFLD) is a global problem and one of the most common liver diseases in the world. Various pharmacological and non-pharmacological therapies seem to be non-effective and the patients are often advised not to expect a positive outcome. Hence, even in the modern Western society many patients reach for traditional herbal products. Silymarin, a lipophilic extract derived from milk thistle (Silybum marianum) has been used in liver and bile disorders for centuries. Strong antifibrotic, antioxidant, antiviral and anti-inflammatory activities of silymarin joined with its metabolic effect proven in vitro make it ideal as a drug candidate in the therapy of NAFLD. Several recent randomized clinical studies have demonstrated that silymarin versus placebo significantly contributes to amelioration of the liver condition affected by NAFLD since it reduces steatosis severity, liver ballooning and fibrosis, followed by lowered aminotransferase levels in both short and long lasting therapies. Silymarin is also as efficient as an insulin sensitizer in the NAFLD therapy, but with less adverse effects. Phase III clinical trials have confirmed silymarin to be currently the best medication for the NAFLD patients, but the problems associated with its standardization, formulation and dosage are yet to be solved. However, green tea (Camellia sinensis) and licorice (Glycyrrhiza glabra) root extracts have also been studied in the clinical trials in the therapy of NAFLD patients. Some other herbal products, which have been tested on animals and have the potential to be used in clinical trials, are briefly summarized in this paper.
A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis. [2018]Silymarin is a complex mixture of 6 major flavonolignans and other minor polyphenolic compounds derived from the milk thistle plant Silybum marianum; it has shown antioxidant, anti-inflammatory and antifibrotic effects, and may be useful in patients with nonalcoholic fatty liver disease (NAFLD). We aimed to study the efficacy of silymarin in patients with nonalcoholic steatohepatitis (NASH)-the more severe form of NAFLD.
Single Laboratory Validation of UHPLC-MS/MS Assays for Six Milk Thistle Flavonolignans in Human Serum. [2023]Extracts of milk thistle, Silybum marianum (L.) Gaertn., are used as dietary supplements for their hepatoprotective, anti-inflammatory, and anti-tumor activities.
Silymarin treatment and reduction of liver enzyme levels in non-alcoholic fatty liver disease: a case report. [2023]Non-alcoholic fatty liver disease (NAFLD) is one of the most frequent chronic liver disorders worldwide. It is closely associated with metabolic syndrome components, including type 2 diabetes, hyperlipidaemia and obesity. To date, no effective drug treatment is available for NAFLD but several clinical trials suggested that silymarin, the active milk thistle extract, has well-documented antioxidant and hepatoprotective properties. In this case report, silymarin 140 mg twice daily decreased liver enzyme activity with a good safety profile in a patient with NAFLD and overweight, supporting silymarin as a promising supportive intervention aimed at normalizing liver activity in NAFLD. This article is part of the Current clinical use of silymarin in the treatment of toxic liver diseases: a case series Special Issue: https://www.drugsincontext.com/special_issues/current-clinical-use-of-silymarin-in-the-treatment-of-toxic-liver-diseases-a-case-series.
Advances in the use of milk thistle (Silybum marianum). [2023]Milk thistle (Silybum marianum) is an herbal supplement used to treat liver and biliary disorders. Silymarin, a mixture of flavanoid complexes, is the active component that protects liver and kidney cells from toxic effects of drugs, including chemotherapy. Although milk thistle has not significantly altered the course of chronic liver disease, it has reduced liver enzyme levels and demonstrated anti-inflammatory and T cell-modulating effects. There is strong preclinical evidence for silymarin's hepatoprotective and anticarcinogenic effects, including inhibition of cancer cell growth in human prostate, skin, breast, and cervical cells. Milk thistle is considered safe and well-tolerated, with gastrointestinal upset, a mild laxative effect, and rare allergic reaction being the only adverse events reported when taken within the recommended dose range. More clinical trials of rigorous methodology, using standardized and well-defined products and dosages, are needed to evaluate the potential of silymarin against liver toxicity, chronic liver disease, and human cancers.
Silymarin improved diet-induced liver damage and insulin resistance by decreasing inflammation in mice. [2019]Silymarin is the main flavonoid extracted from milk thistle, which has been used to treat liver diseases.