Rifaximin treatment for metabolic-associated fatty liver disease

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

This single-center, single-arm early phase 1 study will enroll up to 40 adults with MAFLD who meet specified metabolic criteria. Participants will take oral rifaximin 1200 mg per day (400 mg three times daily) for 24 weeks while maintaining usual activity and following dietary recommendations. Investigators will monitor liver-related labs, metabolic markers, safety labs, and collect mechanistic measures to explore how rifaximin may influence disease progression. Concomitant stable hepatoprotective, lipid-lowering, and antihypertensive therapies are allowed but will be closely monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide written informed consent;
2. Aged 18 to 75 years, regardless of gender;
3. Diagnosed with fatty liver disease within the past 6 months;
4. Presence of at least one of the following metabolic abnormalities:

(1) Overweight or obesity (BMI ≥23 kg/m²) (2) Type 2 diabetes (T2DM) (3) Clinical evidence of metabolic dysfunction (defined as meeting at least two of the following criteria): A. Waist circumference ≥90 cm for males or ≥80 cm for females B. Blood pressure ≥130/85 mmHg and/or diagnosed hypertension under treatment C. Fasting plasma triglycerides ≥1.7 mmol/L (150 mg/dL) or diagnosed hypertriglyceridemia under treatment D. Fasting HDL-C \<1.0 mmol/L (40 mg/dL) for males or \<1.3 mmol/L (50 mg/dL) for females, or diagnosed dyslipidemia under treatment E. Prediabetes: fasting glucose 5.6-6.9 mmol/L (100-125 mg/dL) or 2-hour postprandial glucose 7.8-11.0 mmol/L (140-199 mg/dL) or HbA1c 5.7%-6.4% (39-47 mmol/mol) F. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score ≥2.5 G. Plasma high-sensitivity C-reactive protein (hs-CRP) \>2 mg/L 5. Liver fat content ≥8% as measured by MRI proton density fat fraction (MRI-PDFF).

Exclusion Criteria

1. Cirrhosis - Confirmed by clinical, laboratory, imaging, and/or liver biopsy.
2. Chronic liver disease of other etiologies (e.g., viral/autoimmune hepatitis, alcoholic liver disease, drug-induced liver injury)
3. Secondary hepatic steatosis (e.g., drug-induced, total parenteral nutrition-related, or hypothyroidism-associated);
4. Recent use of intestinal flora-modifying agents, or unstable regimens of medications (including hepatoprotectants, metformin, thiazolidinediones, fibrates, statins, et al) within 4 weeks prior to enrollment;
5. Agents with potential effects on MAFLD progression administered within 12 weeks prior to enrollment, excluding those maintained at stable doses for ≥24 weeks (e.g., Glucagon-like peptide-1 receptor agonists, Dipeptidyl peptidase IV inhibitors, Obeticholic acid, Sodium-glucose cotransporter 2 inhibitors, Resmetirom or anti-obesity medications)
6. Poorly controlled diabetes (HbA1c \>9%)
7. Jaundice (total bilirubin ≥85 μmol/L), or Renal dysfunction (serum creatinine ≥1.2 × ULN)
8. History of bariatric surgery
9. Active or suspected malignancy
10. Severe systemic conditions - Including: Inflammatory diseases (e.g., connective tissue disorders), Biliary/pancreatic disorders, Chronic/acute infections, Severe cardiovascular, pulmonary, or hematologic diseases, Myocardial infarction or stroke within 6 months, Psychiatric disorders
11. HIV infection
12. Known hypersensitivity to rifaximin
13. MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity
14. Pregnancy, lactation, or planned pregnancy
15. Participation in another drug trial within 3 months
16. Other conditions deemed unsuitable by investigators

Where it's running

• Changzheng Hospital, Naval Medical University, shanghai, China
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chuan Yin, M.d.
• Email: ilse1225@163.com
• Phone: +8613482705212

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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.