Discovery of Drug-Targeted Gut Microbiota-Mediated Interindividual Variability in the Therapeutic Efficacy of Silybin Against NASH

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500104129

Enrollment

Unknown

Registered

2025-06-11

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-06-16

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

Conditions

NASH

Interventions

NASH group:NA

Control group:NA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1; Selection of Healthy Subjects (1) Age >=18 years, regardless of sex; (2) Body weight >=50.0 kg (male) or >=45.0 kg (female), with a body mass index (BMI) between 18 and 26 kg/m²; (3)Willingness to provide written informed consent; 2; Selection of NASH Patients (1) Age >=18 years, regardless of sex; (2) No alcohol consumption or ethanol intake =4 weeks; (7) ALT and aspartate aminotransferase (AST) levels <=5× ULN; (8) Radiological confirmation of hepatic steatosis; (9) Willingness to provide written informed consent;.

Exclusion criteria

Exclusion criteria: 1. Selection of Healthy Subjects (1) Use of medications, antibiotics, or probiotics within 2 weeks prior to the study; (2) History of alcohol consumption exceeding 140 g ethanol/week (male) or 70 g ethanol/week (female); (3) Current or past diagnosis of clinically significant disorders (e.g., cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, or metabolic diseases) or conditions that may interfere with study outcomes (e.g., phenylketonuria, gastric ulcer, asthma); (4) Pregnancy, lactation, or planned pregnancy during the study period; (5) Abnormal biochemical test results; (6) Radiological evidence of hepatic steatosis meeting diagnostic criteria for fatty liver; 2. Selection of NASH Patients (1) Diagnosis of alcoholic liver disease, viral hepatitis, drug-induced liver injury, Wilson’s disease, autoimmune liver disease, etc; (2) Severe comorbidities (e.g., malignancy, cardiopulmonary diseases, renal failure); (3) Use of antibiotics or probiotics within 2 weeks prior to the study; (4) History of neurological or psychiatric disorders; (5) Pregnancy, lactation, or planned pregnancy during the study period; (6) Unwillingness to provide informed consent; (7) Concomitant use of antibiotics or probiotics during Silybin treatment.

Design outcomes

Primary

Measure	Time frame
liver function;Gut Microbial DNA;	—

Countries

China

Contacts

Public ContactYao Chen

Xiangya Hospital, Central South University

cbohua@csu.edu.cn+86 137 8722 1049

Outcome results

None listed

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