Could a gut antibiotic shrink fatty liver? small trial aims to find out
NCT ID NCT07185932
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial is testing whether the antibiotic rifaximin can reduce liver fat in people with metabolic fatty liver disease. About 40 adults will take rifaximin pills three times daily for up to 48 weeks, while maintaining diet and exercise. The main goal is to see if liver fat decreases on MRI scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rifaximin (Xifaxan)
- What this could lead to
- If it works, this could point toward a new treatment option for metabolic fatty liver disease using an existing antibiotic.
- What could go wrong
- This is a very early, small pilot study with only 40 people and no placebo group, so results may not be reliable or generalizable. Rifaximin can cause side effects like nausea or diarrhea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2024
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Willing and able to provide written informed consent; 2. Aged 18 to 75 years, regardless of gender; 3. Diagnosed with fatty liver disease within the past 6 months; 4. Presence of at least one of the following metabolic abnormalities: (1) Overweight or obesity (BMI ≥23 kg/m²) (2) Type 2 diabetes (T2DM) (3) Clinical evidence of metabolic dysfunction (defined as meeting at least two of the following criteria): A. Waist circumference ≥90 cm for males or ≥80 cm for females B. Blood pressure ≥130/85 mmHg and/or diagnosed hypertension under treatment C. Fasting plasma triglycerides ≥1.7 mmol/L (150 mg/dL) or diagnosed hypertriglyceridemia under treatment D. Fasting HDL-C \<1.0 mmol/L (40 mg/dL) for males or \<1.3 mmol/L (50 mg/dL) for females, or diagnosed dyslipidemia under treatment E. Prediabetes: fasting glucose 5.6-6.9 mmol/L (100-125 mg/dL) or 2-hour postprandial glucose 7.8-11.0 mmol/L (140-199 mg/dL) or HbA1c 5.7%-6.4% (39-47 mmol/mol) F. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score ≥2.5 G. Plasma high-sensitivity C-reactive protein (hs-CRP) \>2 mg/L 5. Liver fat content ≥8% as measured by MRI proton density fat fraction (MRI-PDFF). Exclusion Criteria 1. Cirrhosis - Confirmed by clinical, laboratory, imaging, and/or liver biopsy. 2. Chronic liver disease of other etiologies (e.g., viral/autoimmune hepatitis, alcoholic liver disease, drug-induced liver injury) 3. Secondary hepatic steatosis (e.g., drug-induced, total parenteral nutrition-related, or hypothyroidism-associated); 4. 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; 5. Agents with potential effects on MAFLD progression administered within 12 weeks prior to enrollment, excluding those maintained at stable doses for ≥24 weeks (e.g., Glucagon-like peptide-1 receptor agonists, Dipeptidyl peptidase IV inhibitors, Obeticholic acid, Sodium-glucose cotransporter 2 inhibitors, Resmetirom or anti-obesity medications) 6. Poorly controlled diabetes (HbA1c \>9%) 7. Jaundice (total bilirubin ≥85 μmol/L), or Renal dysfunction (serum creatinine ≥1.2 × ULN) 8. History of bariatric surgery 9. Active or suspected malignancy 10. Severe systemic conditions - Including: Inflammatory diseases (e.g., connective tissue disorders), Biliary/pancreatic disorders, Chronic/acute infections, Severe cardiovascular, pulmonary, or hematologic diseases, Myocardial infarction or stroke within 6 months, Psychiatric disorders 11. HIV infection 12. Known hypersensitivity to rifaximin 13. MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity 14. Pregnancy, lactation, or planned pregnancy 15. Participation in another drug trial within 3 months 16. Other conditions deemed unsuitable by investigators
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metabolic associated fatty liver disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Changzheng Hospital, Naval Medical University, shanghai, China
RECRUITINGShanghai, Shanghai Municipality, 200003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fatty liver and hepatitis b together harm kidneys? a study digs into the data
- Sleep apnea may signal hidden liver trouble
- Blood protein may reveal hidden nerve damage in diabetes and fatty liver
- Fatty liver? researchers to check uric acid link
- New study probes why diabetes patients develop fatty liver
- New MRI tech could end painful liver biopsies for fatty liver patients