Efficacy and Safety of Rifaximin-α in Treating MASLD
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Changzheng Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to provide written informed consent.
Aged 18 to 75 years, inclusive, regardless of gender.
Diagnosis of hepatic steatosis (fatty liver) within the past 6 months.
Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
Disqualifiers
Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, and/or liver biopsy findings.
Evidence of other specific etiologies of chronic liver disease confirmed by history or laboratory tests, including but not limited to: viral hepatitis (B or C, etc.), autoimmune liver disease, alcohol-related liver disease (defined as >20 g/day for females or >30 g/day for males), drug-induced liver injury, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
Other identifiable causes of hepatic steatosis confirmed by history or laboratory tests, such as: specific medications (e.g., tamoxifen, amiodarone, valproate, methotrexate, glucocorticoids, olanzapine), total parenteral nutrition, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovary syndrome, etc.
Use of medications known to alter gut microbiota (e.g., lactulose, systemic antibiotics, any intestinal microecological preparations) within 4 weeks prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Rifaximin-α (Alfa Wassermann S.p.A., Italy)
DrugParticipants in the treatment group will receive oral Rifaximin-α at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Treatmnet groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The relative change in liver fat content measured by MRI from baseline to 24 weeks.
The relative changes in MRI-measured liver proton density fat fraction (PDFF) at 24 weeks compared to baseline.
Time frame
From enrollment to the end of treatment at 24 weeksSecondary outcomes
1
The absolute change in liver fat content measured by MRI from baseline to 24 weeks.
Absolute changes in MRI-measured liver proton density fat fraction (PDFF) at 24 weeks compared to baseline.
Time frame
From enrollment to the end of treatment at 24 weeks2
Proportion of patients achieving ≥30% reduction in liver fat content measured by MRI-PDFF at 24 weeks of treatment compared to baseline
Proportion of patients achieving ≥30% reduction in liver fat content measured by MRI-PDFF at 24 weeks of treatment compared to baseline
Time frame
From enrollment to the end of treatment at 24 weeks3
The change in liver fat content measured by MRI-PDFF at 12 weeks of treatment
Absolute and relative changes in MRI-measured liver PDFF at 12 weeks compared to baseline.
Time frame
From enrollment to the end of treatment at 12 weeks4
Proportion of patients achieving ≥30% reduction in liver fat content (PDFF) measured by MRI at 12 weeks of treatment compared to baseline.
The proportion of patients whose liver fat content (PDFF), assessed via MRI, decreased by ≥30% from baseline after 12 weeks of treatment.
Time frame
From enrollment to the end of treatment at 12 weeksOther outcomes
1
Changes in liver fat content assessed via MRI-PDFF at 12/24 weeks post-treatment.
Longitudinal changes in liver PDFF measured by MRI at 12 and 24 weeks following treatment discontinuation, comparing these time points to baseline.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov