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Could probiotics help tame fatty liver?

NCT ID NCT04555434

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three different probiotics (Pediococcus pentosaceus, Lactobacillus lactis, and Lactobacillus helveticus) in 89 adults with non-alcoholic fatty liver disease. Participants took probiotic capsules or a placebo daily for 8 weeks, along with a standard liver supplement. Researchers measured liver function, body changes, and gut bacteria to see if the probiotics improved liver health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Probiotics (Pediococcus pentosaceus KID7, Lactobacillus lactis CKDB001, Lactobacillus helveticus CKDB001)
What this could lead to
If successful, this could point toward a simple, safe dietary supplement to help manage fatty liver disease.
What could go wrong
This is an early-phase trial with only 89 participants and an 8-week duration. Results may not apply to everyone, and the effect may be small or temporary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

89 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 62 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hallym University Chuncheon Sacred Heart Hospital

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

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Other studies related to the condition(s) this trial covers.