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Tests treatment safety and results for Metabolic-associated Fatty Liver Disease
Official title Efficacy and Safety of Rifaximin in Treating MAFLD
ClinicalTrials.gov ID: NCT07185932
What this study is testing
What is Rifaximin (Xifaxan)?
Rifaximin (Xifaxan) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metabolic-associated fatty liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
- 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...
You likely can't join if
- 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...
- Agents with potential effects on MAFLD progression administered within 12 weeks prior to enrollment, excluding those maintained at stable doses for...
- Poorly controlled diabetes (HbA1c \>9%)
See the full eligibility criteria
- 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;
- 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...
- 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;
- 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...
- Poorly controlled diabetes (HbA1c \>9%)
- Jaundice (total bilirubin ≥85 μmol/L), or Renal dysfunction (serum creatinine ≥1.2 × ULN)
- History of bariatric surgery
- Active or suspected malignancy
- Severe systemic conditions - Including: Inflammatory diseases (e.g., connective tissue disorders), Biliary/pancreatic disorders, Chronic/acute infections, Severe cardiovascular, pulmonary, or hematologic diseases...
- HIV infection
- Known hypersensitivity to rifaximin
- MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity
- Pregnancy, lactation, or planned pregnancy
- Participation in another drug trial within 3 months
- Other conditions deemed unsuitable by investigators
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.