Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02366052
Other study ID # NUCES_NASH-JGU
Secondary ID SCHA 1015/5-1
Status Completed
Phase Phase 2
First received November 1, 2013
Last updated May 15, 2017
Start date February 1, 2015
Est. completion date May 10, 2017

Study information

Verified date May 2017
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 10, 2017
Est. primary completion date May 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound

OR histologically confirmed NASH

- Age 18 to 75 years

Exclusion Criteria:

- Alcohol intake of more than 30 g/d (men) or 20 g/d (women)

- Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization

- Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)

- Treatment with phenprocoumon or warfarin

- Hepatocellular carcinoma or non-hepatic malignancy

- Decompensated cirrhosis (Child B,C) or a history of decompensation

- Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload

- Bariatric surgery within the last 5 years

- BMI <18,5 kg/m2 or BMI >45 kg/m2

- Liver transplantation

- Heart failure (New York Heart Association Class II - IV)

- Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months

- Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.

- Instable renal insufficiency (changes in serum creatinin > 50% in the last 3 month) or terminal renal insufficiency requiring dialysis

- Uncontrolled hypertension (blood pressure > 180/90 despite therapy)

- Uncontrolled diabetes mellitus defined by hemoglobin A1c > 9

- Food allergies requiring strictly dietary adherence

- Pregnant or nursing women

- Chronic pancreatitis or history of recurring acute pancreatitis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutritional Counseling
Nutritional counseling by a trained nutritionist for 12 weeks.
Dietary Supplement:
Lactobacillus casei shirota (LCS)
The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.
Other:
Nutritional Counseling and LCS
Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.

Locations

Country Name City State
Germany Institut für Ernährungswissenschaften, University Jena Jena
Germany University Medical Center of the Johannes Gutenber Univeristy Mainz

Sponsors (2)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Improvement in measures of nutritional physiology Improvement of nutritional physiology, compliance, self-perceived efficacy, emotional eating behavior using a validated questionnaires. 12 and 24 weeks
Primary Reduction of the M30 antigen in the serum Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury 12 and 24 weeks
Secondary Change in indicators of hepatocellular injury and fibrosis Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan) 12 and 24 weeks
Secondary Change in metabolic risk factors Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed. 12 and 24 weeks
Secondary Saftey and tolerability Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury. 12 and 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4