Testing rifaximin in people with fatty liver disease linked to metabolism
Tests the antibiotic rifaximin in adults with metabolic fatty liver disease.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Rifaximin in Treating MAFLD
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with fatty liver disease linked to metabolic problems. Everyone will take rifaximin for 24 weeks.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Fatty liver disease (MAFLD) diagnosed within the past 6 months, with liver fat of 8% or more on MRI (MRI-PDFF), and at least one metabolic problem such as overweight or obesity (BMI ≥23 kg/m²), type 2 diabetes, or signs of metabolic dysfunction.
- Earlier treatment
- Medicines that change gut bacteria, or changing doses of liver-protecting drugs, metformin, thiazolidinediones, fibrates or statins, within 4 weeks before joining, are not allowed. Other drugs that can affect fatty liver within 12 weeks before joining are not allowed, unless the dose was stable for 24 weeks or more.
- Biomarker or test result
- Liver fat content of 8% or more on MRI (MRI-PDFF).
Main reasons for not taking part
- Cirrhosis, or other liver diseases such as viral or autoimmune hepatitis or alcoholic liver disease
- Poorly controlled diabetes (HbA1c >9% (75 mmol/mol))
- HIV infection
- Pregnancy, breastfeeding or planned pregnancy
- Known allergy to rifaximin
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07185932, who can take part
Where in China
- Changzheng Hospital, Naval Medical University, shanghai, ChinaShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Changzheng Hospital
- Trial code
- NCT07185932
- Record updated
- 22 September 2025
- Original description
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 influence MAFLD progression.Read full original descriptionShow less
Efficacy and Safety of Rifaximin in Treating Metabolic Associated Fatty Liver Disease: A Pilot Trial
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 influence MAFLD progression.
Target Population: patients diagnosed with MAFLD. Intervention: this single-center, single-arm exploratory study will enroll up to 40 eligible MAFLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent. Participants will receive oral rifaximin at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks. Patients will be advised to maintain their usual physical activity and adhere to a recommended dietary plan (e.g., Mediterranean diet). Concurrent therapies such as hepatoprotective agents, lipid-lowering medications, and antihypertensive treatments will remain unchanged, with close monitoring of relevant parameters. No additional prescription or over-the-counter drugs that may affect fatty liver progression or alter gut microbiota composition will be permitted during the study.
The primary endpoint will be assessed at 24 weeks. If liver proton density fat fraction (PDFF) remains ≥ 8% after 24 weeks of rifaximin therapy, treatment will be extended for an additional 12 weeks, followed by reevaluation of PDFF changes. The maximum total treatment duration will not exceed 48 weeks. All patients will undergo a 24-week post-treatment follow-up period after discontinuation of rifaximin.
Investigational Drug: Rifaximin (Alfa Wassermann S.p.A., Italy).
Inclusion: 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: 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; MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity; Participation in another drug trial within 3 months; Chronic liver disease of other etiologies (e.g., viral/autoimmune hepatitis, alcoholic liver disease, drug-induced liver injury); 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; Other conditions deemed unsuitable by investigators; Cirrhosis - Confirmed by clinical, laboratory, imaging, and/or liver biopsy; 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); Pregnancy, lactation, or planned pregnancy.