Probiotic supplement plus lifestyle changes for fatty liver (MASLD)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fu Jen Catholic University Hospital
  New Taipei City, Taiwan Recruiting
• Fu Jen Catholic University Hospital
  New Taipei City, Taiwan Not yet recruiting

Study contacts

• Study coordinator: Kuan Wei Wu
• Email: david800413@gmail.com
• Phone: +886-922-710-756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.