NCT07834125Not yet recruiting
Patients With Cryptogenic Hypertransaminasemia
From the Gut to the Liver: Unraveling the Role of Bacterial Translocation in Cryptogenic Hypertransaminasemia
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2029
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07834125
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Oct 2026 to the primary completion date, 1 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adverse reactions to potentially hepatotoxic drugs.
- Systemic antibiotic or probiotic therapy within the 3 months preceding enrollment.
- Ongoing immunosuppressive therapy.
Other illness
- 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.
- Celiac disease, thyroid disorders, rhabdomyolysis, or known muscle diseases.
- Ongoing acute infections.
- Active malignancy.
Age
- Age \< 18 years.
Other
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.