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

NCT ID: NCT04555434

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-09-11

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Probiotics group

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.

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

• Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day)
• Control group Main ingredient: Crystalline cellulose

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

• Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day)
• Control group Main ingredient: Crystalline cellulose

Interventions

Probiotics

• Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day)
• Control group Main ingredient: Crystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cellulose (Placebo)

Eligibility Criteria

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

• 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)

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ki Tae Suk, Professor

Role: CONTACT

ktsuk@hallym.ac.kr

+82-10-5365-5700

Facility Contacts

Ki Tae Suk

Role: primary

+82-10-5365-5700

Other Identifiers

PRO-NASH

Identifier Type: -

Identifier Source: org_study_id