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Efficacy of lifestyle intervention and rifaximin for metabolic associated fatty liver disease

Efficacy of lifestyle intervention and rifaximin for metabolic associated fatty liver disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046116
Enrollment
Unknown
Registered
2021-05-04
Start date
2021-05-17
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic associated fatty liver disease, MAFLD

Interventions

experimental group:rifaximin
control group:placebo

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: MAFLD patients : 1.Age 18 to 65 years, male or female; 2.MAFLD patient was diagnosed in the outpatient department of Xiangya Hospital of Central South University.The criteria (Jounal of Hepatology,2020) for a positive diagnosis of MAFLD are based on histological (biopsy), imaging or blood biomarker evidence of fat accumulation in the liver (hepatic steatosis) in addition to one of the following three criteria, namely overweight/obesity (BMI>= 23 kg / m^2), presence of type 2 diabetes mellitus (T2DM), or evidence of metabolic dysregulation. 1) The criteria for metabolic disorders are at least two of the following abnormalities: 1-waistline>=90/80cm(male/female);2-Blood pressure >= 130 / 85 mmHg or drug treatment; 3-Plasma triglyceride >= 150 mg / dl (>= 1.70 mmol / L) or special drug treatment; 4-Plasma high density lipoprotein cholesterol: male = 2.5; 7-Plasma C-reactive protein level was > 2 mg / L. 3.Weight change of less than 5% in the last 3-6 months; 4.Provide signed and dated informed consent; 5.Able to take oral drugs and willing to comply with the clinical study protocol; 6.Agree to abide by the provisions of the Lifestyle Notes throughout the study period; Healthy subjects: 1.Roughly matched age and sex according to the composition of enrolled MAFLD subjects; 2.Weight change of less than 5% in the last 3-6 months.

Exclusion criteria

Exclusion criteria: 1.Men drink more than 24g alcohol/day and women drink more than 16g alcohol/day; 2.Allergic to rifaximin; 3.Patients with cirrhosis; 4.Screening patients with viral hepatitis, autoimmune liver, hepatolenticular degeneration and other chronic liver diseases; 5.Hypothyroidism, Cushing's syndrome, medication hormones, total parenteral nutrition, etc.; 6.Patients suffering from serious systemic diseases and malignant tumors; 7.Pregnant or lactating women; 8.Has received bariatric surgery ; 9.Use of antibiotics, probiotics, prebiotics and other drugs that may affect intestinal flora within 3 months. (meet one of the above conditions)

Design outcomes

Primary

MeasureTime frame
Glutamic-pyruvic transaminase;Regression degree of fatty liver with B ultrasound;

Secondary

MeasureTime frame
Body mass index;Insulin resistance index;Waist hip rate;Hypersensitive C-reactive protein;Changes in body composition;HOMA - IR level;Liver hardness level;

Countries

China

Contacts

Public ContactLiu Xiaowei

Xiangya Hospital Central South University

liuxw70@126.com+86 13548762

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026