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Establishment of a non-invasive diagnostic model for advanced fibrosis in patients with NAFLD based on gut microbial signature using artificial intelligence

Establishment of a non-invasive diagnostic model for advanced fibrosis in patients with NAFLD based on gut microbial signature using artificial intelligence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112078
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

metabolic dysfunction-associated steatotic liver disease

Interventions

Index test:gut microbiota 16rRNA sequencing

Sponsors

Shanghai Sixth People`s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with Non-alcoholic fatty liver disease (NAFLD) confirmed by liver biopsy, who meet the following criteria: 1) Age greater than 18 years. 2) Liver histopathology demonstrates hepatic steatosis with ballooning degeneration and lobular inflammation, with or without liver fibrosis. Liver fibrosis grading: Liver tissue fibrosis is graded according to the SAF diagnostic scoring system of the European Fatty Liver Collaboration Group, with grades 0–2 indicating mild fibrosis and grades 3–4 indicating advanced fibrosis.

Exclusion criteria

Exclusion criteria: 1) Excessive alcohol consumption (alcohol intake >30 g/day for men and >20 g/day for women). 2) Patients with concomitant viral hepatitis. 3) Patients with other non-viral liver diseases including drug-induced liver injury, autoimmune hepatitis, and Wilson's disease. 4) Patients with thyroid dysfunction or polycystic ovary syndrome (PCOS).

Design outcomes

Primary

MeasureTime frame
gut microbiota 16rRNA sequencing;Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predicative value;negative predictive value;

Countries

China

Contacts

Public ContactLi Hu

Shanghai Sixth People`s Hospital

lihu32782702@163.com+86 181 1612 0056

Outcome results

None listed

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