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

Chuncheon Sacred Heart Hospital

Status: Unknown

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04555434

PRO-NASH

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 62 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Probiotics group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotics

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotics