Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT04555434
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

A study for evaluating the improvement effect of non-alcoholic steatohepatitis (NASH) of probiotics

Detailed Description

Non-alcoholic fatty liver disease progresses to fatty liver, hepatitis, cirrhosis, and liver cancer, resulting in a high mortality rate. The prevalence of non-alcoholic fatty liver disease at home and abroad is a major social and economic burden. However, there is no cure for non-alcoholic fatty liver disease. Recently, intestinal axis theory related to the development of chronic liver disease and microbial community has emerged. Intake of probiotics is known to play a role in regulating gut microflora. Improvement of non-alcoholic fatty liver disease can be expected through administration of probiotics.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Those who agreed to participate in this study and signed a written consent

2. Adult men and women over 20

3. Patients diagnosed with non-alcoholic fatty liver

   ※ Exclusion criteria for alcoholic liver disease

   • Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
   • 1 bottle of shochu 360 ml * 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) * 5% = 25 (16.5 g)

4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme

   • AST, ALT: 40 or less
   • ALP: 20-130
   • GOT: 0-30, GPT: 0-38
   • GGT: 10-62 (male), 7-35 (female)

Exclusion Criteria

1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.

2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period

3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.

4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)

5. If you have any of the following

   • Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
   • systemic inflammatory disease or immune disease
   • Hepatocellular carcinoma
   • Uncontrolled cardiopulmonary disease
   • Other serious systemic disorders in the heart, lungs, blood, and endocrine system

6. A person with a history of malignancy diagnosis within the last 5 years

7. Pregnant or lactating women

8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions

9. Those who are not suitable for the clinical trial because the investigator judges

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Probiotics	The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.
Placebo group	Probiotics	The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.

Primary Outcome Measures

Name	Time	Method
Gut-Microbiome Composition	Change from Baseline of fecal microbiome at 8 months	Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Demographic characteristics	1 week	The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Primary Outcomes; Liver Function Test	Baseline of AST, ALT, rGT, CHOL, and ALP at first week.	Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\[IU/L\]
Computed Tomography	Change from Baseline of CT image at 8 months	change of the Abdominal ultrasonography or Computed Tomography(CT): Upper abdominal ultrasound or CT to determine the degree of fatty liver disease; ② Fibroscan: Objectively and quantitatively grasp the degree of liver fibrosis by measuring the degree of firmness (elasticity) of the liver
change of BMI	Change from Baseline BMI and weight at 6 months	Compare the body mass index. BMI=Body Weight/(Height)\^2
Secondary Outcomes; Liver Function Test	Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months	Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\[IU/L\]

Trial Locations

Locations (1)

Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of