NCT04555434CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- First submitted
- 1 Jul 2020
- Start date
- 20 Sept 2020
- Primary completion date
- 11 Sept 2022
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04555434
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 89
- From 20 Sept 2020 to the primary completion date, 11 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
Other
- 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)
- Pregnant or lactating women
- Those who are not suitable for the clinical trial because the investigator judges
Who the study is looking for
- 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)
Age in the registry: 21 years to 62 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hallym University Chuncheon Sacred Heart Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.