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New treatment option for Non-Alcoholic Fatty Liver Disease (NAFLD)
Official title Milk Thistle Clinical Trial in Pediatric NAFLD
ClinicalTrials.gov ID: NCT06477146
What this study is testing
What is Milk thistle (MT)?
Milk thistle (MT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-alcoholic fatty liver disease (nafld).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 22
You may be able to join if
- people between the age of 9 to 22 years old diagnosed with non-Alcoholic Fatty Liver Disease (NAFLD) based on current North American Society for...
- 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...
- 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...
- 2\. Risk factors associated with overweight child that warrant screening and inclusion are: a. Central obesity, Family history of NAFLD/non-alcoholic...
- 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...
You likely can't join if
- 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...
- Patients with cirrhosis and hepatic decompensation will be excluded from the study. Hepatic biomarker parameters will be excluded:
- ALT greater than 200 U/L
- AST greater than 200 U/L
- Total bilirubin greater than 2.0 mg/dL
See the full eligibility criteria
- people between the age of 9 to 22 years old diagnosed with non-Alcoholic Fatty Liver Disease (NAFLD) based on current North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Guidelines:
- 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...
- 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: a. Central obesity, Family history of NAFLD/non-alcoholic steatohepatitis(NASH), pre-diabetic or diabetic, dyslipidemia, sleep...
- 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...
- c. (Or) previous findings on Liver Biopsy consistent with NAFLD including hepatic macro-vesicular steatosis, ballooning degeneration or Mallory Denk Bodies 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 (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant...
- Male patients who are sexually active with a partner of child-bearing potential must either be sterile (vasectomy with history of a negative sperm count at least 90 days following the procedure); practice total...
- 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...
- Patients with cirrhosis and hepatic decompensation will be excluded from the study. Hepatic biomarker parameters will be excluded:
- 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
- people 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...
- people with unstable diabetes, or HbA1c \>9% will be excluded from the study.
- people who report binge drinking will be excluded from this study.
- people who partake or state consumption history of tobacco use, vaping, marijuana use, or illicit drug abuse will be excluded from the study.
- people with severe hepatic dysfunction and synthetic dysfunction with hypoalbuminemia (Albumin \ 1.4) will be excluded from the study.
- Exclude people 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): Pediatric Age...
- Breast feeding women will be excluded from this clinical trial.
- people who are participating in other drug trials will be excluded from participating.
- people with a reported or known history of allergy or anaphylactic reaction to Ragweed will be excluded from this study.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.