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Clinical Trials in Italy / NCT07834125
Starting soon Observational

Patients With Cryptogenic Hypertransaminasemia

NCT07834125 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2026-10-01
Last updated
2026-09-22

Condition(s) studied

Cryptogenic Hypertransaminasemia

Study summary

Persistent unexplained elevation of serum aminotransferases (ALT and AST) remains undiagnosed in a subset of patients despite a comprehensive diagnostic work-up. Increasing evidence suggests that alterations in the gut-liver axis, including intestinal dysbiosis, increased intestinal permeability, and bacterial translocation, may contribute to liver inflammation and hepatocellular injury. Bacterial components such as lipopolysaccharide (LPS) may reach the portal circulation and activate hepatic immune pathways through receptors including CD14 and Toll-like receptor 4 (TLR4).

This study aims to investigate the potential role of bacterial translocation in patients with unexplained persistent hypertransaminasemia undergoing liver biopsy. Standard histological evaluation will be integrated with immunohistochemical and molecular analyses of liver biopsy specimens to assess markers associated with bacterial translocation, including bacterial DNA, LPS, and soluble CD14 (sCD14). The study may help clarify the underlying mechanisms of otherwise unexplained hypertransaminasemia and identify potential biomarkers for future clinical use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age ≥ 18 years. * Persistent cryptogenic hypertransaminasemia (elevated ALT and/or AST levels) documented for at least 6 months. For the control group only: normal aminotransferase levels. * No identifiable etiology after a comprehensive clinical, laboratory, and instrumental evaluation. * Ability to provide written informed consent. Exclusion Criteria: * Age \< 18 years. * Histologically documented metabolic dysfunction-associated steatotic liver disease (MASLD). * Alcohol-related liver disease or active alcohol consumption. * Active viral hepatitis. * Hereditary hemochromatosis or other known genetic liver diseases. * Adverse reactions to potentially hepatotoxic drugs. * Celiac disease, thyroid disorders, rhabdomyolysis, or known muscle diseases. * Ongoing acute infections. * Systemic antibiotic or probiotic therapy within the 3 months preceding enrollment. * Ongoing immunosuppressive therapy. * Active malignancy. * Pregnancy.

Primary outcome measure(s)

  • Hepatic LPS Expression — 30-45 month
    Immunohistochemical assessment of lipopolysaccharide (LPS) expression in liver tissue obtained from patients with cryptogenic hypertransaminasemia and control participants.
  • Hepatic LBP Expression — 30-45 month
    Immunohistochemical assessment of lipopolysaccharide-binding protein (LBP) expression in liver tissue obtained from patients with cryptogenic hypertransaminasemia and control participants.
  • Hepatic CD14 Expression — 30-45 month
    Immunohistochemical assessment of CD14 expression in liver tissue obtained from participants with cryptogenic hypertransaminasemia and control participants.
  • Hepatic MD-2 Expression — 30-45 month
    Immunohistochemical assessment of myeloid differentiation factor 2 (MD-2) expression in liver tissue obtained from participants with cryptogenic hypertransaminasemia and control participants.
  • Hepatic TLR2 Expression — 30-45 month
    Immunohistochemical assessment of Toll-like receptor 2 (TLR2) expression in liver tissue obtained from participants with cryptogenic hypertransaminasemia and control participants.
  • Hepatic TLR4 Expression — 30-45 month
    Immunohistochemical assessment of Toll-like receptor 4 (TLR4) expression in liver tissue obtained from patients with cryptogenic hypertransaminasemia and control participants.
  • Hepatic TLR5 Expression — 30-45 month
    Immunohistochemical assessment of Toll-like receptor 5 (TLR5) expression in liver tissue obtained from patients with cryptogenic hypertransaminasemia and control participants.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Roma Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07834125 on ClinicalTrials.gov ↗ ← All trials in Italy