Probiotic supplement plus lifestyle changes for fatty liver (MASLD)
Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This trial will test whether taking a probiotic supplement alongside lifestyle changes can reduce liver fat, improve liver tests, and improve metabolic health in adults with MASLD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fu Jen Catholic University Hospital Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 2 sites (New Taipei City and 1 other locations) |
| Trial ID | NCT07400367 on ClinicalTrials.gov |
What this trial studies
Adults with MASLD and elevated ALT who have ultrasound-confirmed liver steatosis will receive a structured lifestyle modification program and be given either an oral probiotic product or a placebo. Key outcomes include liver steatosis and fibrosis measured by elastography, liver enzymes, and metabolic markers such as fasting glucose, HbA1c, lipids, and measures of insulin resistance. Common exclusions include viral hepatitis, cirrhosis, heavy alcohol use, recent antibiotics, autoimmune or drug-related hepatitis, and use of medications known to induce steatosis. The trial aims to determine whether adding a probiotic to lifestyle change provides measurable benefits beyond lifestyle change alone.
Who should consider this trial
Good fit: Adults with ultrasound-confirmed liver steatosis, ALT ≥ 60 U/L, and at least one cardiometabolic risk factor (for example elevated BMI, hypertension, dyslipidemia, or impaired glucose) are the intended participants.
Not a fit: People with active viral hepatitis, established cirrhosis, excessive alcohol intake, recent antibiotic use, suspected autoimmune or drug-induced hepatitis, or who are taking medications that induce liver steatosis are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding a probiotic to lifestyle therapy could offer a low-risk, accessible way to lower liver fat and improve metabolic and liver-related measures in people with MASLD.
How similar studies have performed: Previous small trials of probiotics in NAFLD/MASLD populations have reported mixed but sometimes modest improvements in liver enzymes and steatosis, so the approach is promising but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Taipei City and 1 other locations
- Fu Jen Catholic University Hospital — New Taipei City, Taiwan (Not_yet_recruiting)
- Fu Jen Catholic University Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Kuan Wei Wu
- Email: david800413@gmail.com
- Phone: +886-922-710-756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.