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

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

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

Study Overview

• Status: Unknown
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: 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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ki Tae Suk, Professor; Phone Number: +82-10-5365-5700; Email: ktsuk@hallym.ac.kr

Study Locations

• Korea, Republic of
  • Gangwon
    • Chuncheon, Gangwon, Korea, Republic of, 200-704
      • Recruiting
      • Hallym University Chuncheon Sacred Heart Hospital
      • Contact: Ki Tae Suk; Phone Number: +82-10-5365-5700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: Cellulose (Placebo)
Placebo Comparator: 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.	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; Other Names: Cellulose (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY	1 week
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.
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
Computed Tomography	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 from Baseline of CT image at 8 months
change of BMI	Compare the body mass index. BMI=Body Weight/(Height)^2	Change from Baseline BMI and weight at 6 months
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

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): September 11, 2020
• Study Completion (Anticipated): September 11, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; Gut microbiota; Liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PRO-NASH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No