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Study identifier: NCT07185932 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Efficacy and Safety of Rifaximin in Treating MAFLD

Condition: Metabolic-associated Fatty Liver Disease  ·  Sponsor: Shanghai Changzheng Hospital

PhaseEARLY_Phase 1
Planned participants40
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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. Inv…

This description comes directly from the study's public registry record.

Talk to the study team

CHUAN YIN, M.D.  ·  +8613482705212  ·  ilse1225@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Changzheng Hospital, Naval Medical University, shanghai, ChinaShanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07185932