Could an antibiotic help reverse fatty liver? new trial launches
NCT ID NCT07381257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a gut-acting antibiotic called rifaximin-α can reduce liver fat in people with metabolic fatty liver disease (MASLD). About 60 adults will take either the drug or just follow diet and exercise advice for 24 weeks. The goal is to see if the drug safely lowers liver fat and helps understand how gut bacteria affect the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Willingness to provide written informed consent. 2. Aged 18 to 75 years, inclusive, regardless of gender. 3. Diagnosis of hepatic steatosis (fatty liver) within the past 6 months. 4. Presence of at least one metabolic/cardiovascular risk factor: A. BMI ≥ 23.0 kg/m², or waist circumference ≥ 90 cm (male) / 80 cm (female). B. Fasting plasma glucose (FPG) ≥ 5.6 mmol/L, or 2-hour postprandial glucose ≥ 7.8 mmol/L, or HbA1c ≥ 5.7%, or documented history of type 2 diabetes mellitus (T2DM) or current use of anti-diabetic medication. C. Fasting serum triglycerides (TG) ≥ 1.70 mmol/L, or current use of medication for hypertriglyceridemia. D. Serum high-density lipoprotein (HDL) cholesterol ≤ 1.0 mmol/L (male) and ≤ 1.3 mmol/L (female), or current use of lipid-lowering medication. E. Blood pressure ≥ 130/85 mmHg, or current use of antihypertensive medication. 5. Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). Exclusion Criteria 1. Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, and/or liver biopsy findings. 2. 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. 3. 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. 4. Use of medications known to alter gut microbiota (e.g., lactulose, systemic antibiotics, any intestinal microecological preparations) within 4 weeks prior to screening. 5. Dose of hepatoprotective or lipid-lowering medications not stabilized for at least 4 weeks prior to screening. 6. Received any Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or remeglutide treatment within 12 weeks prior to screening, or plans to receive such treatment during the study. 7. Dose of medications that may affect MASLD, anti-diabetic agents (excluding GLP-1 RAs and remeglutide), or weight-loss drugs not stabilized for at least 12 weeks prior to screening. 8. Self-reported weight change \>5% within 4 weeks prior to screening. 9. BMI \> 35 kg/m². 10. Poorly controlled glycemia: HbA1c \> 9%. 11. Total bilirubin \> 1.5 mg/dL (except with normal direct bilirubin), or Alanine Aminotransferase (ALT) \> 5 times the Upper Limit of Normal (ULN), or Aspartate Aminotransferase (AST) \> 5 times ULN, or Alkaline Phosphatase (ALP) \> 2 times ULN. 12. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m². 13. History of or planned bariatric/metabolic therapy, including but not limited to endoscopic interventions, surgical procedures, or Traditional Chinese Medicine therapies. Exceptions may be made if previous interventions have been reversed or removed (e.g., intragastric balloon, subcutaneous threads) for more than 12 weeks. 14. History of or current hepatocellular carcinoma (HCC). 15. Diagnosis of any malignancy within the past 5 years, except for malignancies with low risk of metastasis or death (estimated 5-year overall survival \>90%), such as effectively treated early-stage gastrointestinal cancer, carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer. 16. Significant comorbid conditions affecting the cardiovascular, respiratory, rheumatological/immunological, hematological, biliary, or pancreatic systems; or history of myocardial infarction, stroke, heart failure, unstable angina, or transient ischemic attack within 6 months prior to screening; or presence of psychiatric disorders. 17. HIV infection. 18. Known allergy or hypersensitivity to rifaximin. 19. Contraindications to MRI, such as incompatible metallic implants, claustrophobia, or body size exceeding scanner capacity. 20. Pregnant or lactating women, women of childbearing potential not using effective contraception, or individuals planning pregnancy. 21. Participation in another investigational drug trial within 3 months prior to screening. 22. Any other condition deemed by the investigator to be unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Changzheng Hospital, Naval Medical University, shanghai, China
RECRUITINGShanghai, China
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Other studies related to the condition(s) this trial covers.
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