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

NCT04555434 | Completed Phase 1 DMC

• 1 other identifier: PRO-NASH
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and improve metabolic and hepatic outcomes in MASLD; however, clinical evidence regarding next-generation probiotic strains remains limited. This study was designed to evaluate the effects of three next-generation probiotic strains-Lactobacillus delbrueckii subsp. lactis (LL001), Lactobacillus helveticus (LH001), and Pediococcus pentosaceus KID7 (PPKID7)-on liver function parameters and gut microbiome composition in patients with MASLD. We conducted a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 110 adult patients diagnosed with MASLD were screened for eligibility. Eligible participants were randomly assigned to receive one of the three probiotic formulations (3 capsules per day, total 9×10⁹ CFU) or placebo for 8 weeks. All participants received concomitant silymarin during the intervention period. Clinical assessments, serum samples, and stool samples were collected at baseline and at the end of the intervention. Liver function parameters were predefined as the primary outcome measure. Secondary outcomes included changes in anthropometric parameters, serum metabolic markers, gut microbiota composition assessed by 16S rRNA gene sequencing, and lipidomic profiles derived from serum and fecal samples. Compliance was monitored throughout the study period. The study protocol was approved by the institutional review board, and written informed consent was obtained from all participants prior to enrollment.

Conditions

Non-Alcoholic Fatty Liver Disease; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Probiotics; Liver disease; Gut microbiota

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Probiotics group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Probiotics 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

Also known as: Cellulose (Placebo)

Placebo group; Probiotics group

Eligibility Criteria

• Age: 21 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
• 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)
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: collaborator
• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 200-704, South Korea

Location

Related Publications (1)

• Won SM, Joung H, Park IG, Han SH, Ham YL, Han JS, Kwon Y, Kim DJ, Suk KT. The effects of next generation probiotics on metabolic dysfunction-associated steatotic liver disease: a parallel, double-blind, randomized, placebo-controlled trial. J Transl Med. 2025 Dec 9;24(1):61. doi: 10.1186/s12967-025-07478-z.

  PMID: 41366779 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Interventions

Probiotics; Cellulose

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: September 18, 2020
• Study Start: September 20, 2020
• Primary Completion: September 11, 2022
• Study Completion: December 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

KR (1)