Clinical trials: NASH - Nonalcoholic Steatohepatitis
Non-Alcoholic Fatty Liver Disease
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic…
- Trial name
- NCT01285362
- Testing
- Fish Oil Supplementation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Inflammation, Fibrosis
Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We aim to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD.
- Conditions
- Inflammation, Fibrosis, Insulin Resistance
- Trial name
- VITENAFLD (NCT00655018)
- Testing
- Vitamin treatment (alpha tocopherol plus ascorbic acid)
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
Non-Alcoholic Fatty Liver Disease
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
The goal of this study is to evaluate the role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis and fibrosis with a Fibroscan machine.
- Trial name
- NCT04671186
- Testing
- Culturelle (Lactobacillus rhamnosus strain GG)
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Northwell Health
Fatty Liver
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
- Trial name
- TONIC (NCT00063635)
- Testing
- Metformin, Vitamin E
- Where
- 10 sites in United States
- Volunteers
- 173 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Pediatric Obesity, Metabolic Syndrome
Cardio-Metabolic Risk Evaluation in Overweight and Obese Children
Metabolic and cardio-vascular complications can often appear in overweight and obese children from an early age. Currently, there are few studies in the specialized literature that correlate clinical, biological and ultrasound…
- Conditions
- Pediatric Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver, Atherosclerosis
- Trial name
- CardMetSOb (NCT05908877)
- Testing
- History and Clinical evaluation, Biological evaluation of the metabolic syndrome and components, Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage
- Where
- Romania
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Neoped - Centru de Pediatrie
Nonalcoholic Fatty Liver Disease (NAFLD)
Anti-LPS Antibody Treatment for Pediatric NAFLD
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver…
- Trial name
- NCT03042767
- Testing
- IMM-124E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Miriam Vos, MD
NASH - Nonalcoholic Steatohepatitis
Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"
Studies in recent years have demonstrated that the commensal intestinal flora (microbiome) plays a key role in the development of nonalcoholic steatohepatitis (NASH).
- Trial name
- ADLH (NCT03897218)
- Testing
- oatmeal flakes with prebiotic food supplements, millet flakes
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 84 people
- Sponsor
- RWTH Aachen University
Nonalcoholic Fatty Liver, Metabolic Syndrome
Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
Non-invasive diagnosis and treatment of nonalcoholic fatty liver disease (NAFLD) remain unmet medical needs. Aim of this study is to investigate the blood levels of three hormonal systems related to obesity, insulin resistance…
- Trial name
- NAFLD (NCT03986684)
- Where
- Greece
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hippocration General Hospital
NAFLD, NASH - Nonalcoholic Steatohepatitis
Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness.
- Trial name
- NCT04591106
- Testing
- Magnetic resonance imaging (MRI), Magnetic resonance elastography (MRE), Prototype MRE soft flexible passive transducer paddle
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Morbid Obesity, Obstructive Sleep Apnea Syndrome
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01045499
- Testing
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Jeffrey L Zitsman, MD
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice.
- Trial name
- NCT02815891
- Where
- 72 sites in United States, Germany and 1 more
- Volunteers
- 7,330 people
- Sponsor
- Target PharmaSolutions, Inc.
Nonalcoholic Steatohepatitis
Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH) is a serious type of nonalcoholic fatty liver disease (NAFLD), which is characterized by lobular inflammation and apoptosis resulting from hepatic steatosis in the absence of excessive alcohol…
- Trial name
- NCT05733897
- Testing
- hydroxychloroquine
- Where
- 2 sites in Taiwan
- Volunteers
- 150 people
- Sponsor
- National Taiwan University Hospital
Chronic Pancreatitis, Inflammatory Bowel Diseases
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect…
- Conditions
- Chronic Pancreatitis, Inflammatory Bowel Diseases, Hepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- GREAT1 (NCT04306939)
- Testing
- venipuncture, Questionnaires, Additional Sample Collections
- Where
- United States
- Volunteers
- 120,000 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).
- Trial name
- NCT02863757
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Humanity and Health Research Centre
Colorectal Neoplasms, Nonalcoholic Fatty Liver Disease
Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm
The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for CRC.
- Trial name
- NWC (NCT01657773)
- Testing
- Ultrasound examination and Colonoscopy examination
- Where
- China
- Volunteers
- 2,315 people, healthy volunteers welcome
- Sponsor
- Wenzhou Medical University
NAFLD - Nonalcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
This is a single-center, randomized, double-blinded, placebo-controlled, parallel treatment groups phase 2a study of curcumin for pediatric nonalcoholic fatty liver disease (NAFLD).
- Trial name
- NCT04109742
- Testing
- phosphatidylcholine-curcumin complex supplement
- Sponsor
- Columbia University
Nonalcoholic Fatty Liver Disease (NAFLD)
Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD).
- Trial name
- CyNCh (NCT01529268)
- Testing
- DR cysteamine bitartrate capsule
- Where
- 10 sites in United States
- Volunteers
- 169 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NAFLD
Effects of Tomato Products in Children With NAFLD
CONTROLLED TRIAL ON THE EFFECT OF TOMATO PRODUCTS IN OBESE CHILDREN WITH NON ALCOHOLIC FATTY LIVER DISEASE Aim of the study To evaluate the effect of the addition of a daily dose of lycopene enriched tomato sauce on the progress…
- Trial name
- NCT03463967
- Testing
- Lycopene-enriched tomato juice, Energy-restricted diet
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- Federico II University
Bariatric Surgery Candidate, NAFLD
Effectiveness of Bariatric Surgery for NAFLD/NASH
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery. This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH with fribrosis, to explore the…
- Conditions
- Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis
- Trial name
- NCT04366999
- Testing
- SG, RYGB, OAGB
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Beijing Friendship Hospital