Non-Alcoholic Fatty Liver Disease (NAFLD)Phase 2NCT06477146
Milk Thistle Clinical Trial in Pediatric NAFLD
A Phase 2 study testing Milk thistle (MT), Lifestyle Modification and Fibroscan in people with Non-Alcoholic Fatty Liver Disease (NAFLD), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 22 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Milk thistle (MT), Lifestyle Modification and Fibroscan
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 31 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects 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 below) or obese children:
- 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:
- Central obesity, Family history of NAFLD/non-alcoholic steatohepatitis(NASH), pre-diabetic or diabetic, dyslipidemia, sleep apnea)
- 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.
Show all 12Show fewer
- 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
- 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 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 (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [> 12 consecutive months without menses]).
- Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable ≥ 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice.
- 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 abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female patients of childbearing potential) from the time of screening until 30 days after the last dose of study drug administration. Male patients must agree not to donate sperm for a period of 30 days after the last dose of study drug administration.
Who cannot join
- 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.
- 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
Show all 20Show fewer
- ALP greater than 500 U/L
- INR greater than 1.4
- GGT greater than 200 U/L
- Subjects 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 psychiatric illness).
- Subjects with unstable diabetes, or HbA1c >9% will be excluded from the study.
- Subjects who report binge drinking will be excluded from this study.
- Subjects who partake or state consumption history of tobacco use, vaping, marijuana use, or illicit drug abuse will be excluded from the study.
- Subjects with severe hepatic dysfunction and synthetic dysfunction with hypoalbuminemia (Albumin < 3.0 g/dL), thrombocytopenia (platelet count <140,000/ml3), or coagulopathy (INR >1.4) will be excluded from the study.
- Exclude subjects 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 Group Premature 0.3 - 1.0 mg/dL Neonates 0.2 - 0.9 mg/dL 2-12 months 0.2 - 0.4 mg/dL 1-2 years 0.2 - 0.5 mg/dL 3-4 years 0.3 - 0.7 mg/dL 5-6 years 0.3 - 0.7 mg/dL 7-8 years 0.2 - 0.6 mg/dL 9-10 years 0.3 - 0.7 mg/dL 11-12 years 0.3 - 0.9 mg/dL 13-15 years 0.4 - 0.9 mg/dL
- Males 16 years and older 0.6 - 1.2 mg/dL Females 16 years and older 0.5 - 1.0 mg/dL
- Breast feeding women will be excluded from this clinical trial.
- Subjects who are participating in other drug trials will be excluded from participating.
- Subjects with a reported or known history of allergy or anaphylactic reaction to Ragweed will be excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Alok Bapatla, MD, (216)844-1765, Alok.Bapatla@UHhospitals.org
About this study
Official title: Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)
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.
- Being tested
- Milk thistle (MT), Placebo, Lifestyle Modification, Fibroscan
- Keywords
- Silymarin, Fatty Liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
The placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition.
Lifestyle ModificationBehavioural
The primary instructions for lifestyle modification are:
- 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.
- Adequate hydration- 4-5 bottles of water a day.
- Limitation of sugar-free beverages- once daily and 1-2 (8 oz) cups of skim/1% milk (or dairy alternative) daily.
- Avoidance of beverages with added sugar such as soda, Kool-Aid, juice, and Gatorade.
- Ideal consumption- three meals daily(breakfast, lunch, dinner)and one snack.
- Snack Goal <200 calories. If a 2nd, 3rd, etc. snack is desired it will only be a vegetable.
- Five servings of fruits/vegetables per day.
- Each food we recommend eating should have dietary fiber >3 grams/serving. Ideally >5 grams/serving.
- The given survival guide will have all information regarding serving size and portion allotment.
- "MyPlate.gov" handout given which will guide participants in relation to portion control.
FibroscanDevice
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 group | Role | What they receive |
|---|---|---|
| Milk Thistle | Experimental | Patients will be given Milk Thistle capsules based on weight by mouth once or twice daily for 12 weeks. Receives: Drug: Milk thistle (MT); Behavioral: Lifestyle Modification; Device: Fibroscan |
| Placebo | Experimental | Patients will be give 500mg capsule based on weight by mouth once or twice daily for 12 weeks. Receives: Drug: Placebo; Behavioral: Lifestyle Modification; Device: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test.
Measured: Up to 12 weeks
Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan.
Normal kPa results are usually between 2 and 7 kPa, with the highest possible result of 75 kPa.
Measured: Up to 12 weeks
Percent of Hepatic Steatosis as measured by FibroScan.
Percentage of steatosis will be correlated with the CAP score- 200 to 400db/m2
Measured: Up to 12 weeks
Secondary outcomes (1)
Number of adverse events as measured by patient report.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start19 Dec 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas J Sferra, MD, University Hospitals Cleveland Medical Center
- Investigators
- Thomas Sferra, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477146
- Sponsor's protocol ID
- STUDY20231215
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06477146
- Acronym / sponsor ID
- STUDY20231215
- Keywords
- Silymarin, Fatty Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Thistle | Experimental | Drug: Milk thistle (MT), Behavioral: Lifestyle Modification, Device: FibroscanPatients will be given Milk Thistle capsules based on weight by mouth once or twice daily for 12 weeks. |
| Placebo | Experimental | Drug: Placebo, Behavioral: Lifestyle Modification, Device: FibroscanPatients will be give 500mg capsule based on weight by mouth once or twice daily for 12 weeks. |
Who may qualify
- Ages
- 9 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Subjects 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 below) or obese children:
- 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
- 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 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 (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [> 12 consecutive months without menses]).
Key exclusion criteria (20 listed)
- 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.
- Patients with cirrhosis and hepatic decompensation will be excluded from the study. Hepatic biomarker parameters will be excluded:
- Subjects 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 psychiatric illness).
- Subjects with unstable diabetes, or HbA1c >9% will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk thistle (MT)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. | Drug | Milk Thistle |
| PlaceboThe placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition. | Drug | Placebo |
| Lifestyle ModificationThe 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. | Behavioural | Milk Thistle, Placebo |
| FibroscanFibroScan 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. | Device | Milk Thistle, Placebo |
Primary outcome
Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test.
Time frame: Up to 12 weeks
Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan.
Time frame: Up to 12 weeks
Normal kPa results are usually between 2 and 7 kPa, with the highest possible result of 75 kPa.
Percent of Hepatic Steatosis as measured by FibroScan.
Time frame: Up to 12 weeks
Percentage of steatosis will be correlated with the CAP score- 200 to 400db/m2
1 secondary outcome
Number of adverse events as measured by patient report.
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Alcoholic Fatty Liver Disease (NAFLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Sferra, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milk thistle (MT), Lifestyle Modification and Fibroscan in people with Non-Alcoholic Fatty Liver Disease (NAFLD), run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alok Bapatla, MD ((216)844-1765, Alok.Bapatla@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test. (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.