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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Non-Alcoholic Fatty Liver Disease focused on measuring Probiotics, Liver disease, Gut microbiota

Eligibility Criteria

21 Years - 62 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Hallym University Chuncheon Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics group

Placebo group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Demographic characteristics
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Primary Outcomes; Liver Function Test
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Gut-Microbiome Composition
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
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 of BMI
Compare the body mass index. BMI=Body Weight/(Height)^2
Secondary Outcomes; Liver Function Test
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]

Secondary Outcome Measures

Full Information

First Posted
July 1, 2020
Last Updated
September 14, 2020
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04555434
Brief Title
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH
Official Title
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 11, 2020 (Anticipated)
Study Completion Date
September 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Probiotics, Liver disease, Gut microbiota

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
Cellulose (Placebo)
Intervention Description
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
Primary Outcome Measure Information:
Title
Demographic characteristics
Description
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Time Frame
1 week
Title
Primary Outcomes; Liver Function Test
Description
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Time Frame
Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Title
Gut-Microbiome Composition
Description
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Time Frame
Change from Baseline of fecal microbiome at 8 months
Title
Computed Tomography
Description
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
Time Frame
Change from Baseline of CT image at 8 months
Title
change of BMI
Description
Compare the body mass index. BMI=Body Weight/(Height)^2
Time Frame
Change from Baseline BMI and weight at 6 months
Title
Secondary Outcomes; Liver Function Test
Description
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Time Frame
Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Those who agreed to participate in this study and signed a written consent Adult men and women over 20 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) 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: Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period Those who have continuously consumed medicines or health functional foods that affect liver function within the past month. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials) 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 A person with a history of malignancy diagnosis within the last 5 years Pregnant or lactating women Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions Those who are not suitable for the clinical trial because the investigator judges
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Tae Suk, Professor
Phone
+82-10-5365-5700
Email
ktsuk@hallym.ac.kr
Facility Information:
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon
ZIP/Postal Code
200-704
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Tae Suk
Phone
+82-10-5365-5700

12. IPD Sharing Statement

Learn more about this trial

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

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