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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555434
• Other study ID #: PRO-NASH
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 11, 2020

Study information

• Verified date: July 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: Ki Tae Suk, Professor
• Phone: +82-10-5365-5700
• Email: ktsuk[@]hallym.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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