Clinical trial NCT04555434: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Probiotics
Liver disease
Gut microbiota
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Demographic characteristics
timeFrame: 1 week
measure: Primary Outcomes; Liver Function Test
timeFrame: Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
measure: Gut-Microbiome Composition
timeFrame: Change from Baseline of fecal microbiome at 8 months
measure: Computed Tomography
timeFrame: Change from Baseline of CT image at 8 months
measure: change of BMI
timeFrame: Change from Baseline BMI and weight at 6 months
measure: Secondary Outcomes; Liver Function Test
timeFrame: Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwon
Study officials:
References: