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NCT07185932
Efficacy and Safety of Rifaximin in Treating MAFLD
EARLY_PHASE1 trial testing Rifaximin (Xifaxan) in Metabolic-associated Fatty Liver Disease in 40 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Shanghai Changzheng Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 10 August 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Rifaximin (Xifaxan) — full drug profile →
Conditions studied
- Metabolic-associated Fatty Liver Disease — all drugs for Metabolic-associated Fatty Liver Disease →
Sponsor
Shanghai Changzheng Hospital
Who can join
Adults 18 to 75, any sex, with Metabolic-associated Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07185932
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Currently open trials in the same condition.
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Other Shanghai Changzheng Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07185932 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Changzheng Hospital
- Last refreshed: 22 September 2025
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