NCT07381257

Efficacy and Safety of Rifaximin-α in Treating MASLD

Efficacy and Safety of Rifaximin-α in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized, Open-Label, Controlled Pilot Clinical Trial

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study Objective: To evaluate the efficacy and safety of Rifaximin-α in the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), and investigate the underlying mechanisms by which Rifaximin-α influences MASLD progression. Target Population: Patients diagnosed with MASLD. Intervention: This trial is a multicenter, prospective, randomized, controlled study. Enrolled MASLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent will be randomized in a 2:1 ratio to the Rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin-α treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. Both groups of patients will enter a 24-week follow-up period after completing the 24-week treatment. During the study, patients' existing foundational treatments (such as liver-protecting, lipid-lowering, glucose-lowering, and antihypertensive therapies) will be maintained. Relevant indicators will be closely monitored. And avoid the use of medications known to alter the gut microbiota, such as lactulose, antibiotics, and various types of intestinal microecological preparations. Investigational Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy).

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions

Type	Name	Description
DRUG	Rifaximin-α (Alfa Wassermann S.p.A., Italy)	Participants in the treatment group will receive oral Rifaximin-α at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: China