Efficacy and Safety of Rifaximin in Treating MAFLD
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 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Rifaximin (Xifaxan)
DrugParticipants will receive oral rifaximin at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Rifaximin treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The change in liver fat content measured by MRI at 24 weeks of treatment.
Absolute and 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
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 weeks2
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 24 weeks3
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 24 weeks4
Changes in liver function indicators after 12 weeks of treatment compared to baseline.
Changes in liver function parameters 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 during extended treatment (36 or 48 weeks) and at 12/24 weeks post-treatment.
Longitudinal changes in liver PDFF measured by MRI during extended therapy (36 or 48 weeks) and after treatment discontinuation (12 and 24 weeks post-treatment), compared to baseline values
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov