Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
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. 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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 22
Healthy Volunteers: f
View:

∙ 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:

‣ a. 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.

• 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.

Locations
United States
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Alok Bapatla, MD
Alok.Bapatla@UHhospitals.org
(216)844-1765
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 20
Treatments
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.
Sponsors
Leads: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov