[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607236":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rifaximin treatment group","EXPERIMENTAL","Participants will receive oral rifaximin.",[13],"Drug: Rifaximin (Xifaxan)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Rifaximin (Xifaxan)","Participants will receive oral rifaximin at a dosage of 1200 mg\u002Fday (400 mg, three times daily) for 24 weeks.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"CHUAN YIN, M.D.","CONTACT","+8613482705212","ilse1225@163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Changzheng Hospital, Naval Medical University, shanghai, China","RECRUITING","Shanghai","Shanghai Municipality","200003","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43],{"name":20,"role":24,"phone":44,"phoneExt":20,"email":26},"13482705212",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Wei-Fen Xie","Director, Department of Gastroenterology, Changzheng Hospital","100607236","early-phase-1-efficacy-and-safety-of-rifaximin-in-treating-mafld-100607236",false,"NCT07185932","Efficacy and Safety of Rifaximin in Treating MAFLD","Efficacy and Safety of Rifaximin in Treating Metabolic Associated Fatty Liver Disease: A Pilot Trial","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent;\n2. Aged 18 to 75 years, regardless of gender;\n3. Diagnosed with fatty liver disease within the past 6 months;\n4. Presence of at least one of the following metabolic abnormalities:\n\n(1) Overweight or obesity (BMI ≥23 kg\u002Fm²) (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\u002F85 mmHg and\u002For diagnosed hypertension under treatment C. Fasting plasma triglycerides ≥1.7 mmol\u002FL (150 mg\u002FdL) or diagnosed hypertriglyceridemia under treatment D. Fasting HDL-C \\\u003C1.0 mmol\u002FL (40 mg\u002FdL) for males or \\\u003C1.3 mmol\u002FL (50 mg\u002FdL) for females, or diagnosed dyslipidemia under treatment E. Prediabetes: fasting glucose 5.6-6.9 mmol\u002FL (100-125 mg\u002FdL) or 2-hour postprandial glucose 7.8-11.0 mmol\u002FL (140-199 mg\u002FdL) or HbA1c 5.7%-6.4% (39-47 mmol\u002Fmol) F. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score ≥2.5 G. Plasma high-sensitivity C-reactive protein (hs-CRP) \\>2 mg\u002FL 5. Liver fat content ≥8% as measured by MRI proton density fat fraction (MRI-PDFF).\n\nExclusion Criteria\n\n1. Cirrhosis - Confirmed by clinical, laboratory, imaging, and\u002For liver biopsy.\n2. Chronic liver disease of other etiologies (e.g., viral\u002Fautoimmune hepatitis, alcoholic liver disease, drug-induced liver injury)\n3. Secondary hepatic steatosis (e.g., drug-induced, total parenteral nutrition-related, or hypothyroidism-associated);\n4. 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;\n5. 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)\n6. Poorly controlled diabetes (HbA1c \\>9%)\n7. Jaundice (total bilirubin ≥85 μmol\u002FL), or Renal dysfunction (serum creatinine ≥1.2 × ULN)\n8. History of bariatric surgery\n9. Active or suspected malignancy\n10. Severe systemic conditions - Including: Inflammatory diseases (e.g., connective tissue disorders), Biliary\u002Fpancreatic disorders, Chronic\u002Facute infections, Severe cardiovascular, pulmonary, or hematologic diseases, Myocardial infarction or stroke within 6 months, Psychiatric disorders\n11. HIV infection\n12. Known hypersensitivity to rifaximin\n13. MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity\n14. Pregnancy, lactation, or planned pregnancy\n15. Participation in another drug trial within 3 months\n16. Other conditions deemed unsuitable by investigators","ALL","18 Years","75 Years",{"count":60,"type":61},40,"ESTIMATED","INTERVENTIONAL",[64],"EARLY_PHASE1","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.\n\nTarget 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\u002Fday (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.\n\nThe 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.\n\nInvestigational Drug: Rifaximin (Alfa Wassermann S.p.A., Italy).",[67],"Metabolic-associated Fatty Liver Disease",[69,70],"metabolic-associated fatty liver disease","Rifaximin","2025-09-12",{"date":73,"type":74},"2025-09-22","ACTUAL",{"date":76,"type":74},"2024-08-10",{"date":78,"type":61},"2027-12-31",{"name":5,"class":6},1]