Status:
RECRUITING
Efficacy and Safety of Rifaximin in Treating MAFLD
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Metabolic-associated Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
Study Objective: to evaluate the efficacy and safety of rifaximin in the treatment of metabolic-associated fatty liver disease (MAFLD), and investigate the underlying mechanisms by which rifaximin inf...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Willing and able to provide written informed consent;
- Aged 18 to 75 years, regardless of gender;
- Diagnosed with fatty liver disease within the past 6 months;
- 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
- Cirrhosis - Confirmed by clinical, laboratory, imaging, and/or liver biopsy.
- Chronic liver disease of other etiologies (e.g., viral/autoimmune hepatitis, alcoholic liver disease, drug-induced liver injury)
- Secondary hepatic steatosis (e.g., drug-induced, total parenteral nutrition-related, or hypothyroidism-associated);
- 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;
- 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)
- Poorly controlled diabetes (HbA1c \>9%)
- Jaundice (total bilirubin ≥85 μmol/L), or Renal dysfunction (serum creatinine ≥1.2 × ULN)
- History of bariatric surgery
- Active or suspected malignancy
- 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
- HIV infection
- Known hypersensitivity to rifaximin
- MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity
- Pregnancy, lactation, or planned pregnancy
- Participation in another drug trial within 3 months
- Other conditions deemed unsuitable by investigators
Exclusion
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07185932
Start Date
August 10 2024
End Date
December 31 2027
Last Update
September 22 2025
Active Locations (1)
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1
Changzheng Hospital, Naval Medical University, shanghai, China
Shanghai, Shanghai Municipality, China, 200003