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Gut bacteria boost may help fight fatty liver

NCT ID NCT07400367

Disease control Sponsor: Fu Jen Catholic University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a multi-strain probiotic supplement, taken alongside standard lifestyle advice, can improve liver health in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The trial will enroll 80 adults with elevated liver enzymes and fatty liver. Participants will receive either the probiotic or a placebo for 12 weeks, and researchers will measure changes in liver stiffness (fibrosis), fat content, and metabolic risk factors like blood sugar and cholesterol.

What this could mean

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

Active substance
multi-strain probiotic (Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, Lactobacillus reuteri GL-104)
What this could lead to
If it works, this could point toward a simple, safe add-on treatment to help manage MASLD and reduce liver damage.
What could go wrong
This is a small, early-stage trial (80 people) testing a dietary supplement, not a drug. Results may not be dramatic or apply to everyone, and the effect on liver fibrosis is still uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * ALT ≥ 60 U/L * Liver steatosis identified by ultrasound * Meet at least one cardiometabolic criteria: 1. BMI ≥ 25 kg/m2 (Asian ≥23) 2. Waist circumference: \> 94cm (M) 80cm(F) 3. Fasting blood glucose ≥ 100 mg/dL 4. HbA1c ≥ 5.7 5. Receiving treatment of diabetes 6. Receiving treatment of Hypertension 7. Average home blood pressure: ≥ 130/85 mmHg 8. TG ≥ 150 mg/dL 9. HDL ≤ 40 mg/dL 10. Receiving treatment of dyslipidemia Exclusion Criteria: * HBsAg(+) * Anti-HCV (+) * Cirrhosis * Excessive alcohol intake ( Male over 210g/wk; Female over 140mg/wk) * Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+)) * Could not rule out drug related hepatitis * Receiving drug that might induce liver steatosis: * Glucocorticoids * Amiodarone * Tamoxifen * Methotrexate * Valproate * Tetracycline * Chemotherapeutic agents * Receiving immune modulators or biologics * Receiving antibiotics within 1 month * Receiving any cancer treatment * Have diagnosis of "Catastrophic Illness" defined by Health Administration of Taiwan * eGFR\<60 * Pregnancy * Currently enrolled in other dietary or pharmacology clinical trial

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease Insulin Resistance metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Cardiometabolic risk factors Insulin resistance Liver elastography Liver function test Liver steatosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fu Jen Catholic University Hospital

    NOT_YET_RECRUITING

    New Taipei City, Taiwan

  • Fu Jen Catholic University Hospital

    RECRUITING

    New Taipei City, Taiwan

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